hypothesis for feasibility study

Guide to Conducting a Feasibility Study

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So you’re thinking of a launching a new venture? Entering a new market? Launching a new product? It’s estimated that only one in fifty business ideas are actually commercially viable and so you’ll want to understand the viability of any proposed project before you invest your time, energy and money into it. That’s why you need a feasibility study.

Why do you need a feasibility study  .

With such a low success rate of new business ventures a business feasibility study is the best way to learn whether you have an idea that could work and guard against wastage of further investment. If the results are positive, then the outcome of the feasibility study can be used as the basis for a full business plan allowing your to proceed with a clearer view of the risks involved and move forward quicker. If it’s negative then you’ve skilfully avoided wasting time and money on a venture that wouldn’t have worded out.

What is a feasibility study?  

A feasibility study aims to make a recommendation as to the likely success of a venture. At the heart of any feasibility study is a hypothesis or question that you want to answer.  Examples include “is there a demand for a X new product or product feature”, “should we enter Y market” and “should we launch Z new venture”.

How to conduct a feasibility study?  

Once you’ve got a clear hypothesis or question that you want to answer, you need to look at five areas that will impact the feasibility of your idea. Let’s look at each of these in turn:

Market Feasibility

Is the market in question attractive? Are there high barrier to entry? Is it of a size that will support our ambitions? Is it growing? Are there any regulatory or legislative requirements to enter or participate in the market?

Technical Feasibility

What technical skills/ability/knowledge/equipment is required? Do you have or could you source the technical expertise required? Do you fully understand the technical requirements underpinning your hypothesis? Could you manufacture / develop the product or service with the resources you have available?

Business Model Feasibility

How will the idea make money? How will you attract users? What costs will you have to pay? Have you modelled the financials? Do you have access to the funding needed? What legal entity structure would you need?

Management Model Feasibility

Who will lead the venture? Do you have the skills and expertise required to manage and operate the venture/product/market? Does the team have the time needed to deliver the venture? If not, can they be recruited or are their skills hard to find?

Exit Feasibility

Do you have a plan to exit the venture and do you need one?

When competing a feasibility study each of the above areas should have a recommendation as to whether it’s feasible or not from that specific perspective factoring in the resources you have available.  This should conclude with a recommendation based on the analysis as to if the venture is or isn’t feasible and the key data points that underpin that recommendation.

Remember that a great feasibility study should not just give you a go / no-go decision. It should provide either a spring board to move forward, highlighting the key areas to focus on to achieve success or a useful analysis highlighting the key obstacles that make the venture unfeasible and should be considered for any future ideas. Even if the answer is no, it’s not a wasted effort, the analysis will leave you better informed for future decisions.

A feasibility study is an essential tool for anyone looking at a new venture. It’s very easy to get excited by a new idea of proposition and steam ahead spending time and money without having a clear view as to whether it’s viable or not. A feasibility study should be your first stop to maximise the returns on your time, energy and investment.

Best of luck with your feasibility studies!

Chris Purcell @ Prussel & Co

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• How to conduct a feasibility study: Tem ...

How to conduct a feasibility study: Templates and examples

Conducting a feasibility study is an important step in successful project management. By evaluating the viability of a proposed project, a feasibility study helps you identify potential challenges and opportunities, ensuring you make informed decisions. In this guide, we’ll walk you through how to conduct a feasibility study with practical templates and real-world examples, designed for project managers seeking to optimize their project planning process.

It can be exciting to run a large, complex project that has a huge potential impact on your organization. On the one hand, you’re driving real change. On the other hand, failure is intimidating. 

What is a feasibility study? 

A feasibility study—sometimes called a feasibility analysis or feasibility report—is a way to evaluate whether or not a project plan could be successful. A feasibility study evaluates the practicality of your project plan in order to judge whether or not you’re able to move forward with the project. 

It does so by answering two questions: 

Does our team have the required tools or resources to complete this project? 

Will there be a high enough return on investment to make the project worth pursuing? 

Benefits of conducting a feasibility study

There are several key benefits to conducting a feasibility study before launching a new project:

Confirms market opportunities and the target market before investing significant resources

Identifies potential issues and risks early on

Provides in-depth data for better decision making on the proposed project's viability

Creates documentation on expected costs and benefits, including financial analysis

Obtains stakeholder buy-in by demonstrating due diligence

Feasibility studies are important for projects that represent significant investments for your business. Projects that also have a large potential impact on your presence in the market may also require a feasibility assessment. 

As the project manager , you may not be directly responsible for driving the feasibility study, but it’s important to know what these studies are. By understanding the different elements that go into a feasibility study, you can better support the team driving the feasibility study and ensure the best outcome for your project.

When should you conduct a feasibility analysis?

A feasibility study should be conducted after the project has been pitched but before any work has actually started. The study is part of the project planning process. In fact, it’s often done in conjunction with a SWOT analysis or project risk assessment , depending on the specific project. 

Feasibility studies help: 

Confirm market opportunities before committing to a project

Narrow your business alternatives

Create documentation about the benefits and disadvantages of your proposed initiative

Provide more information before making a go-or-no-go decision

You likely don’t need a feasibility study if:

You already know the project is feasible

You’ve run a similar project in the past

Your competitors are succeeding with a similar initiative in market

The project is small, straightforward, and has minimal long-term business impact

Your team ran a similar feasibility analysis within the past three years

One thing to keep in mind is that a feasibility study is not a project pitch. During a project pitch, you’re evaluating whether or not the project is a good idea for your company and whether the goals of the project are in line with your overall strategic plan. Typically, once you’ve established that the project is a good idea, you'll run a feasibility study to confirm that the project is possible with the tools and resources you have at your disposal. 

Types of feasibility studies

There are five main types of feasibility studies: technical feasibility, financial feasibility, market feasibility (or market fit), operational feasibility, and legal feasibility. Most comprehensive feasibility studies will include an assessment of all five of these areas.

Technical feasibility

A technical feasibility study reviews the technical resources available for your project. This study determines if you have the right equipment, enough equipment, and the right technical knowledge to complete your project objectives . For example, if your project plan proposes creating 50,000 products per month, but you can only produce 30,000 products per month in your factories, this project isn’t technically feasible. 

Financial feasibility

Financial feasibility describes whether or not your project is fiscally viable. A financial feasibility report includes a cost-benefit analysis of the project. It also forecasts an expected return on investment (ROI) and outlines any financial risks. The goal at the end of the financial feasibility study is to understand the economic benefits the project will drive. 

Market feasibility

The market feasibility study is an evaluation of how your team expects the project’s deliverables to perform in the market. This part of the report includes a market analysis, a market competition breakdown, and sales projections.

Operational feasibility

An operational feasibility study evaluates whether or not your organization is able to complete this project. This includes staffing requirements, organizational structure, and any applicable legal requirements. At the end of the operational feasibility study, your team will have a sense of whether or not you have the resources, skills, and competencies to complete this work. 

Legal feasibility

A legal feasibility analysis assesses whether the proposed project complies with all relevant legal requirements and regulations. This includes examining legal and regulatory barriers, necessary permits, licenses, or certifications, potential legal liabilities or risks, and intellectual property considerations. The legal feasibility study ensures that the project can be completed without running afoul of any laws or incurring undue legal exposure for the organization.

Feasibility assessment checklist

Most feasibility studies are structured in a similar way. These documents serve as an assessment of the practicality of a proposed business idea. Creating a clear feasibility study helps project stakeholders during the decision making process. 

The essential elements of a feasibility study are: 

An executive summary describing the project’s overall viability

A description of the product or service being developed during this project

Any technical considerations , including technology, equipment, or staffing

The market survey , including a study of the current market and the marketing strategy 

The operational feasibility study evaluates whether or not your team’s current organizational structure can support this initiative

The project timeline

Financial projections based on your financial feasibility report

6 steps to conduct a feasibility study

You likely won’t be conducting the feasibility study yourself, but you will probably be called on to provide insight and information. To conduct a feasibility study, hire a trained consultant or, if you have an in-house project management office (PMO) , ask if they take on this type of work. In general, here are the steps they’ll take to complete this work: 

1. Run a preliminary analysis

Creating a feasibility study is a time-intensive process. Before diving into the feasibility study, it’s important to evaluate the project for any obvious and insurmountable roadblocks. For example, if the project requires significantly more budget than your organization has available, you likely won’t be able to complete it. Similarly, if the project deliverables need to be live and in the market by a certain date but won’t be available for several months after that, the project likely isn’t feasible either. These types of large-scale obstacles make a feasibility study unnecessary because it’s clear the project is not viable.

2. Evaluate financial feasibility

Think of the financial feasibility study as the projected income statement for the project. This part of the feasibility study clarifies the expected project income and outlines what your organization needs to invest—in terms of time and money—in order to hit the project objectives. 

During the financial feasibility study, take into account whether or not the project will impact your business's cash flow. Depending on the complexity of the initiative, your internal PMO or external consultant may want to work with your financial team to run a cost-benefit analysis of the project. 

3. Run a market assessment

The market assessment, or market feasibility study, is a chance to identify the demand in the market. This study offers a sense of expected revenue for the project and any potential market risks you could run into. 

The market assessment, more than any other part of the feasibility study, is a chance to evaluate whether or not there’s an opportunity in the market. During this study, it’s critical to evaluate your competitor’s positions and analyze demographics to get a sense of how the project will go. 

4. Consider technical and operational feasibility

Even if the financials are looking good and the market is ready, this initiative may not be something your organization can support. To evaluate operational feasibility, consider any staffing or equipment requirements this project needs. What organizational resources—including time, money, and skills—are necessary in order for this project to succeed? 

Depending on the project, it may also be necessary to consider the legal impact of the initiative. For example, if the project involves developing a new patent for your product, you will need to involve your legal team and incorporate that requirement into the project plan.

5. Review project points of vulnerability

At this stage, your internal PMO team or external consultant have looked at all four elements of your feasibility study—financials, market analysis, technical feasibility, and operational feasibility. Before running their recommendations by you and your stakeholders, they will review and analyze the data for any inconsistencies. This includes ensuring the income statement is in line with your market analysis. Similarly, now that they’ve run a technical feasibility study, are any liabilities too big of a red flag? (If so, create a contingency plan !) 

Depending on the complexity of your project, there won’t always be a clear answer. A feasibility analysis doesn’t provide a black-and-white decision for a complex problem. Rather, it helps you come to the table with the right questions—and answers—so you can make the best decision for your project and for your team.

6. Propose a decision

The final step of the feasibility study is an executive summary touching on the main points and proposing a solution. 

Depending on the complexity and scope of the project, your internal PMO or external consultant may share the feasibility study with stakeholders or present it to the group in order to field any questions live. Either way, with the study in hand, your team now has the information you need to make an informed decision.

Feasibility study examples

To better understand the concepts behind feasibility assessments, here are two hypothetical examples demonstrating how these studies can be applied in real-world scenarios.

Example 1: New product development

A consumer goods company is considering launching a new product line. Before investing in new product development, they conduct a feasibility study to assess the proposed project.

The feasibility study includes:

Market research to gauge consumer interest, assess competitor offerings, and estimate potential market share for the target market.

Technological considerations, including R&D requirements, production processes, and any necessary patents or certifications.

In-depth financial analysis projects sales volumes, revenue, costs, and profitability over a multi-year period.

Evaluation of organizational readiness, including the skills of the current management team and staff to bring the new product to market.

Assessment of legal feasibility to ensure compliance with regulations and identify any potential liability issues.

The comprehensive feasibility study identifies a promising market opportunity for the new business venture. The company decides to proceed with the new project, using the feasibility report as a template for their business development process. The study helps secure funding from key decision-makers, setting this start-up product initiative up for success.

Example 2: Real estate development deal

A property developer is evaluating the feasibility of purchasing land for a new residential community. They commission a feasibility study to determine the viability of this real estate development project.

The feasibility assessment covers:

Detailed analysis of the local housing market, including demand drivers, comparable properties, pricing, and absorption rates.

Site planning to assess the property's capacity, constraints, and technological considerations.

In-depth review of legal feasibility, including zoning, permitting, environmental regulations, and other potential legal hurdles.

Financial analysis modeling various development scenarios and estimating returns on investment.

Creation of an opening day balance sheet projecting the assets, liabilities, and equity for the proposed project.

Sensitivity analysis to evaluate the impact of changes in key assumptions on the project's scope and profitability.

The feasibility study concludes that while the real estate start-up is viable, it carries significant risk. Based on these findings, the developer makes an informed decision to move forward, but with a revised project's scope and a phased approach to mitigate risk. The comprehensive feasibility analysis proves critical in guiding this major investment decision.

Which phase of the project management process involves feasibility studies?

Feasibility studies are a key part of the project initiation and planning phases. They are typically conducted after a project has been conceptualized but before significant resources are invested in detailed planning and execution.

The purpose of a feasibility assessment is to objectively evaluate the viability of a proposed project, considering factors such as technical feasibility, market demand, financial costs and benefits, legal requirements, and organizational readiness. By thoroughly assessing these aspects, a feasibility study helps project stakeholders make an informed go-or-no-go decision.

While feasibility studies are a critical tool in the early stages of project management, they differ from other planning documents like project charters, business cases, and business plans. Here's a closer look at these key differences:

Feasibility study vs. project charter

A project charter is a relatively informal document to pitch your project to stakeholders. Think of the charter as an elevator pitch for your project objectives, scope, and responsibilities. Typically, your project sponsor or executive stakeholders review the charter before ratifying the project. 

A feasibility study should be implemented after the project charter has been ratified. This isn’t a document to pitch whether or not the project is in line with your team’s goals—rather, it’s a way to ensure the project is something you and your team can accomplish.

Feasibility study vs. business case

A business case is a more formalized version of the project charter. While you’d typically create a project charter for small or straightforward initiatives, you should create a business case if you are pitching a large, complex initiative that will make a major impact on the business. This longer, more formal document will also include financial information and typically involve more senior stakeholders. 

After your business case is approved by relevant stakeholders, you'll run a feasibility study to make sure the work is doable. If you find it isn’t, you might return to your executive stakeholders and request more resources, tools, or time in order to ensure your business case is feasible.

Feasibility study vs. business plan

A business plan is a formal document outlining your organization’s goals. You typically write a business plan when founding your company or when your business is going through a significant shift. Your business plan informs a lot of other business decisions, including your three- to five-year strategic plan . 

As you implement your business and strategic plan, you’ll invest in individual projects. A feasibility study is a way to evaluate the practicality of any given individual project or initiative.

Achieve project success with Asana

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How to Do a Feasibility Study: To Build, or Not To Build?

Suren Karapetyan, MBA, is a senior product manager focused on AI-driven SaaS products. He thrives in the fast-paced world of early stage startups and finds the product-market fit for them. His portfolio is quite diverse, ranging from background noise cancellation tools for work-from-home folks to customs clearance software for government agencies.

Is the juice worth the squeeze? A rigorous feasibility analysis can rescue you from investing resources into a product that shouldn't—or can't —be developed. Here's how to do it, step-by-step.

Let’s play a game. How many cool product ideas can you come up with in a day? 10? 20? My record was 32. But, let’s be honest, having a cool idea is not equivalent to building a successful product.

As product managers who struggle to build and grow products every day, we know about this very well.

But does this mean that we should automatically discard all of our ideas? Of course not. Instead, you should analyze the potential risks and problems related to that proposed project and focus on the ones that are likely to succeed. Enter: the feasibility study.

What is a Feasibility Study?

In product management, a feasibility study, or "feasibility analysis," is the process of reviewing a product idea and understanding your company’s/team’s ability to build that product and make it a success in the market. You will also have a preliminary idea of the different risks and challenges you are likely to face when working on that product.

You would usually evaluate your product from different points of view and ask yourself these questions:

• Are we able to build the technology required for this product to work?
• What does the unit economics for it look like? Would the idea be profitable?
• Are there any legal and compliance limitations that we need to take into consideration?
• Will the market actually like our product and buy it?

By conducting a wide variety of studies, you will eventually have answers to most of these questions and have a more or less solid idea of whether building that product is worth the trouble.

Why Do You Need to Do a Feasibility Study Before Giving Your Product Idea the Green Light?

Let me be brutally honest. A good product idea is barely responsible for 20% of your success. The remaining 80% depends on your ability to build and grow it.

Most of the time, if you apply your critical thinking and study that idea, you will find that the product you envision requires a technology that does not exist yet or you will have to enter a fiercely competitive market.

So, the billion-dollar idea that came to your mind last week is worth nothing unless a project feasibility study confirms that it’s something doable.

The First Draft Of Your Business Plan Will Probably Suck

I want to talk a bit about business plans. There’s a common misconception among founders that the business plan they have just drafted is perfect, and they are automatically bound to success by following it (and no proper feasibility study is needed).

Yes, a well-drafted business plan will definitely increase your likelihood of success. But let’s not forget that whatever you create is simply the first draft. From my experience, you will end up revising it at least a couple of times based on the knowledge you gain about your users and the market.

So, to speed things up for you and make these revisions as early as possible, you have no choice but to conduct a full-scale feasibility study.

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A Step-by-Step Guide to Conducting a Feasibility Analysis

Yes, at first glance, a feasibility analysis might look like a massive undertaking. However, let’s not forget that everything included in it is research that you might have already done (as part of your regular process) or plan to do anyway.

So, let’s see what each phase of this analysis is about and how you can conduct it.

Phase 1: Preliminary Analysis & Project Scope Definition

Our first step would be to document the idea and clearly define what it is about. My go-to platform for doing this is Craft.io (but you can use any other tool like Google Docs, Powerpoint, etc).

I’ll be using Craft.io's idea management module for this, as it facilitates collaboration with other stakeholders.

Let’s start by creating a new idea in the app by clicking on “+Create” > “Idea.”

The idea we want to explore involves building an app that will help companies track and manage their ecological footprint. Let’s call it the EcoFriendly Insights Platform and add relevant information to the idea we created.

First off, we will need an executive summary of what it is.

The point of preliminary analysis is to have a high-level view of the product idea and decide whether it is worth spending time and resources on the full-scale study.

To help our stakeholders with their decision-making, we will add a short SWOT analysis to it.

The final element required for this phase is the scope definition—a high-level explanation of product functionality and expected results. Let’s add that to the idea, too.

As we have all the necessary information ready, we’ll set the prioritization method to RICE (this is what I mainly use for startup idea evaluation) and send the idea link to our stakeholders.

The next steps would be for your stakeholders to review the idea, add comments, and set the RICE scores. Based on all of this, you (along with your leadership) will then decide whether to give this idea a green light or not.

Phase 2: Market Feasibility Analysis (or Market Research)

That’s right. To understand the probability of your product successfully entering your market and growing in it, you will need to conduct a good ol’ market analysis and understand the marketing strategy in your project plan.

Now, let’s tackle each element in your market survey one by one:

Market Size

We’ll need to use public data sources like data.org to understand the number of SMBs in our target market (US and UK in this case). This number will give us the TAM ( total addressable market )—500,000.

Based on the same source, we find that the SAM (Serviceable Available Market) is 200,000 SMBs.

Next, we aim to get 5% of the market (a standard goal in the industry) in the first 3 years. So, our SOM (Serviceable Obtainable Market) is 10,000.

Finally, through a series of interviews, we know that the average SMB is ready to pay $500 - $2,000 a year for sustainability solutions—converting our SOM in the arena of $5m - $20m.

Customer Needs

We’ll conduct a series of interviews and surveys by attending relevant trade shows and using specialized tools like Respondent.io to find the right people to talk to.

With the help of these interviews, we will understand the following:

• Who our users are and what are the realities they're living in?
• What are the alternative solutions they are using and where are they falling short?
• What are the minimal requirements in terms of functionality for a sustainable product?
• Which platforms do they use in their day-to-day operations that need to integrate with our tool?

We can then gather and analyze all of this data and create our user persona (including their demographics). However, for the feasibility study, the entire persona is not necessary. You can create a short summary that covers the most important learnings from your users.

From the imaginary interviews we have done, we find out that the main problem is that SMBs understand that they need to work on their sustainability to comply with local regulations and improve their reputation, but they have no idea where to start.

Competitor Analysis

Finally, we need to admit that there is no real blue ocean market out there and you will almost certainly have competitors to deal with. So, we’ll need to understand who they are as well.

From my experience, the quickest way to understand your competitors is to do the following:

• Interview their users and see what they like and hate about the competitor's product.
• Sign up for their platform and list the different features and Jobs to be Done they cover (you will then create a table comparing them to your product as well as to other competitors' products).
• Look at their G2 or TrustPilot reviews. Again, you will find loads of interesting feedback from users there.
• Run SEMRush or Ahrefs on their website to see their primary acquisition channels.

Based on all of this, you will prepare your competitor profiles and understand where your product stands in the market.

Again, add the summary and not the entire doc for the feasibility analysis.

As a result, we will have something that looks like this:

I have still kept the document in an Idea state, but you can also turn it into an agile epic at this point.

Phase 3: Technical Feasibility Analysis

Even if the market looks promising and you have a good idea of how you can handle competition, there’s another major factor that you need to consider— can you even build it?

Technical feasibility is usually about these two aspects:

• The existence of the necessary technology to solve that problem. You can’t build a Dyson sphere even if you have the smartest minds out there working with you.
• Your ability to hire and finance the creation of a new technology. Technically, you could go to Mars if you were willing to out-rocketship Elon Musk. But could you finance that project? My money says no.

There’s also the time constraint. If it takes you 10+ years to build something, the chances are high that the market will change drastically by then and your product will not be able to enter it.

To conduct a technical feasibility analysis, you will need to ask your engineering team (or external engineers if you don’t have a team yet) to analyze your requirements and come up with a high-level technical solution.

Here’s how we will handle it with Craft.io.

As it is not us but a different stakeholder conducting this research, we will need to create a “task” under our idea and assign it to them.

We will then open the dependencies tab of our idea and select it.

With the dependency added, we will not consider our feasibility analysis done until our tech team closes its dependent task and gives us the tech evaluation results.

Regarding the results themselves, they will usually look something like this.

Based on these technological considerations, we can see that our product is not really complex and we have the necessary technical resources to develop it.

Phase 4: Financial Feasibility Analysis (or Economic Feasibility)

The next phase of our feasibility study is about your potential costs and revenue. Here, you will need to get an answer to the million-dollar question of any business—is my business idea profitable?

There are two sides to this analysis—overall financials and unit economics.

For the first item, we will need the help of our finance, HR, engineering, and marketing/sales teams as we will need to figure out the total cost of development (including salaries), infrastructure costs, and the projected revenue for the next couple of years.

It means that, in Craft.io, we will need to create a couple more dependencies and assign them to each team. The result will look something like this in our idea document.

Here, we have the summary from the projected income statement, data from our balance sheet, financial projections, cash flow, liability calculation, return on investment calculation, and other high-level financial metrics and forecasts.

Regarding the second element of the financials analysis, we will need to determine a single customer's profitability and understand the LTV/CAC ratio. To ensure sustainable scaling, the goal is to have a lifetime value at least three times larger than the cost of acquisition.

Here’s what the unit economics analysis would look like.

Our new project idea looks promising from a financial standpoint. The initial costs are not small, but the unit economics are looking good.

Author's Tip

Be careful with these numbers! They are rough estimates, and your actual financials are unlikely to be this rosy.

Phase 5: Operational Feasibility Analysis with Your Project Management Team

Sometimes, the potential risks that your product can face are not related to the market or the tech under its hood. Instead, they rest on your operational capabilities, organizational structure, and processes.

For instance, you might not have the customer support capacity to serve your clients' needs and, as a result, end up with massive churn.

Therefore, operational feasibility is another aspect that you should pay attention to. This is something to discuss with your project managers as well as the team leads from all divisions.

To organize this properly, you can create a leadership team in Craft.io and assign the task/dependency for Operational Feasibility to them. We do this by opening Settings > Team Manager > Invite

We’ll then rename the default team name to “leadership team.”

After creating the task and selecting the leadership team as the assignee, everyone in that team will get the notification, open the task, and start working on it collaboratively.

The result of this collaboration should look something like this:

Based on this assessment, we see that there are team members of certain professions that we need to hire, which is an operational risk considering the time and effort needed to source that talent.

We also lack proper CX capacity and would need to expand our support team.

Both are serious staffing risks (and have a strong impact on the go/no-go decision) that we need to consider when evaluating our new product idea.

Phase 6: Security and Legal Feasibility

Finally, we need to make sure that our product is compliant with all relevant security standards and government regulations. The types of standards and laws to comply with will depend on the nature of your product as well as the countries where you will operate.

For instance, if you want to get customers from the EU, you have no choice but to comply with GDPR’s legal requirements. From my experience collaborating with the legal and security experts in my company, it is a better option to make the entire product compliant with GDPR and any other major regulation (e.g. HIPAA for medical data or CalOPPA for California residents).

This phase also includes the risk assessment of legal consequences and preparing a contingency plan in case our business case or idea faces serious legal challenges during its lifecycle.

This way, you will rid yourself of the extra hassle of offering your product in different ways to different markets. Plus, compliance with these rules for the worldwide audience will give you an extra reputation boost as you position yourself as a security-first company.

Bonus Phase : AI Feasibility Analysis

As a person working with AI products, I cannot omit this step. This is especially important considering the immense popularity of AI solutions for products and the fact that you will most likely end up using AI, too.

You might think that AI model development feasibility analysis should be part of the technical feasibility phase. That’s logical, but no.

AI is a completely different world and the risks associated with it are different from tech risks.

For instance, before starting to build a model, you need to be sure that you can gather the right training data (and in the right amount). If you can’t find quality training data, then what are you going to train your model with?

There’s also the risk of your models behaving unethically (or even being racist). Just read the latest news on Google Gemini ’s ethically bizarre behavior .

The Feasibility Report: Your Final Deliverable

Your final deliverable is the Feasibility Analysis Report. It’s simply a single document that has combined the information from all of the phases described in this article. There is nothing special here; simply add all of the summary analyses from all of your teams to a file and call it a day.

You can keep it in the form of a Craft.io idea or convert it into a PDF file.

Alternatively, if you have the time, you can create a PowerPoint/Slides presentation where you mention the most important pieces of information from each phase. You can show this during a feasibility analysis meeting to your key decision-makers and send them the full PDF later for their review. This way, you can make sure that they are making informed decisions for that new business idea.

Avoid Building Unrealistic Products

Product managers have a mindset of “everything is possible.” That’s great, and you should definitely keep thinking that way. However, you should also acknowledge that some product ideas are highly risky and are not worth the effort.

So, to let you use your precious time on something that has a real potential for success, a feasibility analysis should be a requirement for all of your product ideas. (At least, the ones you're actually serious about.)

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What Is a Feasibility Study? How to Conduct One for Your Project

Why is a feasibility study so important in project management? For one, the feasibility study or feasibility analysis is the foundation upon which your project plan resides. That’s because the feasibility analysis determines the viability of your project. Now that you know the importance, read on to learn what you need to know about feasibility studies.

What Is a Feasibility Study?

A feasibility study is simply an assessment of the practicality of a proposed project plan or method. This is done by analyzing technical, economic, legal, operational and time feasibility factors. Just as the name implies, you’re asking, “Is this feasible?” For example, do you have or can you create the technology that accomplishes what you propose? Do you have the people, tools and resources necessary? And, will the project get you the ROI you expect?

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Feasibility study template

Use this free Feasibility Study Template for Word to manage your projects better.

What’s the Importance of a Feasibility Study?

A project feasibility study should be done during the project management life cycle after the business case has been completed. So, that’s the “what” and the “when” but how about the “why?” Why is it important to conduct a feasibility study?

An effective feasibility study points a project in the right direction by helping decision-makers have a holistic view of the potential benefits, disadvantages, barriers and constraints that could affect its outcome. The main purpose of a feasibility study is to determine whether the project can be not only viable but also beneficial from a technical, financial, legal and market standpoint.

What Is Included in a Feasibility Study Report?

The findings of your project feasibility study are compiled in a feasibility report that usually includes the following elements.

• Executive summary
• Description of product/service
• Technology considerations
• Product/service marketplace
• Marketing strategy
• Organization/staffing
• Financial projections
• Findings and recommendations

Free Feasibility Study Template

Use this free feasibility study template for Word to begin your own feasibility study. It has all the fundamental sections for you to get started, and it’s flexible enough to adapt to your specific needs. Download yours today.

Types of Feasibility Study

There are many things to consider when determining project feasibility, and there are different types of feasibility studies you might conduct to assess your project from different perspectives.

Pre-Feasibility Study

A pre-feasibility study, as its name suggests, it’s a process that’s undertaken before the feasibility study. It involves decision-makers and subject matter experts who will prioritize different project ideas or approaches to quickly determine whether the project has fundamental technical, financial, operational or any other evident flaws. If the project proposal is sound, a proper feasibility study will follow.

Technical Feasibility Study

A technical feasibility study consists in determining if your organization has the technical resources and expertise to meet the project requirements . A technical study focuses on assessing whether your organization has the necessary capabilities that are needed to execute a project, such as the production capacity, facility needs, raw materials, supply chain and other inputs. In addition to these production inputs, you should also consider other factors such as regulatory compliance requirements or standards for your products or services.

Economic Feasibility Study

Also called financial feasibility study, this type of study allows you to determine whether a project is financially feasible. Economic feasibility studies require the following steps:

• Before you can start your project, you’ll need to determine the seed capital, working capital and any other capital requirements, such as contingency capital. To do this, you’ll need to estimate what types of resources will be needed for the execution of your project, such as raw materials, equipment and labor.
• Once you’ve determined what project resources are needed, you should use a cost breakdown structure to identify all your project costs.
• Identify potential sources of funding such as loans or investments from angel investors or venture capitalists.
• Estimate the expected revenue, profit margin and return on investment of your project by conducting a cost-benefit analysis , or by using business forecasting techniques such as linear programming to estimate different future outcomes under different levels of production, demand and sales.
• Estimate your project’s break-even point.
• Conduct a financial benchmark analysis with industrial averages and specific competitors in your industry.
• Use pro forma cash flow statements, financial statements, balance sheets and other financial projection documents.

Legal Feasibility Study

Your project must meet legal requirements including laws and regulations that apply to all activities and deliverables in your project scope . In addition, think about the most favorable legal structure for your organization and its investors. Each business legal structure has advantages and disadvantages when it comes to liability for business owners, such as limited liability companies (LLCs) or corporations, which reduce the liability for each business partner.

Market Feasibility Study

A market feasibility study determines whether your project has the potential to succeed in the market. To do so, you’ll need to analyze the following factors:

• Industry overview: Assess your industry, such as year-over-year growth, identify key direct and indirect competitors, availability of supplies and any other trends that might affect the future of the industry and your project.
• SWOT analysis: A SWOT analysis allows organizations to determine how competitive an organization can be by examining its strengths, weaknesses and the opportunities and threats of the market. Strengths are the operational capabilities or competitive advantages that allow an organization to outperform its competitors such as lower costs, faster production or intellectual property. Weaknesses are areas where your business might be outperformed by competitors. Opportunities are external, such as an underserved market, an increased demand for your products or favorable economic conditions. Threats are also external factors that might affect your ability to do well in the market such as new competitors, substitute products and new technologies.
• Market research: The main purpose of market research is to determine whether it’s possible for your organization to enter the market or if there are barriers to entry or constraints that might affect your ability to compete. Consider variables such as pricing, your unique value proposition, customer demand, new technologies, market trends and any other factors that affect how your business will serve your customers. Use market research techniques to identify your target market, create buyer personas, assess the competitiveness of your niche and gauge customer demand, among other things.

7 Steps to Do a Feasibility Study

If you’re ready to do your own feasibility study, follow these 7 steps. You can use this free feasibility study template to help you get started.

1. Conduct a Preliminary Analysis

Begin by outlining your project plan . You should focus on an unserved need, a market where the demand is greater than the supply and whether the product or service has a distinct advantage. Then, determine if the feasibility factors are too high to clear (i.e. too expensive, unable to effectively market, etc.).

2. Prepare a Projected Income Statement

This step requires working backward. Start with what you expect the income from the project to be and then what project funding is needed to achieve that goal. This is the foundation of an income statement. Factor in what services are required and how much they’ll cost and any adjustments to revenues, such as reimbursements, etc.

Related: Free Project Management Templates

3. Conduct a Market Survey or Perform Market Research

This step is key to the success of your feasibility study, so make your market analysis as thorough as possible. It’s so important that if your organization doesn’t have the resources to do a proper one, then it is advantageous to hire an outside firm to do so.

Market research will give you the clearest picture of the revenues and return on investment you can realistically expect from the project. Some things to consider are the geographic influence on the market, demographics, analyzing competitors, the value of the market and what your share will be and if the market is open to expansion (that is, in response to your offer).

4. Plan Business Organization and Operations

Once the groundwork of the previous steps has been laid, it’s time to set up the organization and operations of the planned project to meet its technical, operational, economic and legal feasibility factors. This isn’t a superficial, broad-stroke endeavor. It should be thorough and include start-up costs, fixed investments and operating costs. These costs address things such as equipment, merchandising methods, real estate, personnel, supply availability, overhead, etc.

5. Prepare an Opening Day Balance Sheet

This includes an estimate of the assets and liabilities, one that should be as accurate as possible. To do this, create a list that includes items, sources, costs and available financing. Liabilities to consider are such things as leasing or purchasing land, buildings and equipment, financing for assets and accounts receivables.

6. Review and Analyze All Data

All of these steps are important, but the review and analysis are especially important to ensure that everything is as it should be and that nothing requires changing or tweaking. Take a moment to look over your work one last time.

Reexamine your previous steps, such as the income statement, and compare them with your expenses and liabilities. Is it still realistic? This is also the time to think about risk and come up with any contingency plans .

7. Make a Go/No-Go Decision

You’re now at the point to make a decision about whether or not the project is feasible. That sounds simple, but all the previous steps lead to this decision-making moment. A couple of other things to consider before making that binary choice are whether the commitment is worth the time, effort and money and whether it aligns with the organization’s strategic goals and long-term aspirations.

Feasibility Study Examples

Here are some simple feasibility study examples so you have a better idea of what a feasibility study is used for in different industries.

Construction Feasibility Study

For this construction feasibility study example, let’s imagine a large construction company that’s interested in starting a new project in the near future to generate profits.

• Pre-Feasibility Study: The first step is to conduct a preliminary feasibility study. It can be as simple as a meeting where decision-makers will prioritize projects and discuss different project ideas to determine which poses a bigger financial benefit for the organization.
• Technical Feasibility Study: Now it’s time to estimate what resources are needed to execute the construction project, such as raw materials, equipment and labor. If there’s work that can’t be executed by the company with its current resources, a subcontractor will be hired to fill the gap.
• Economic Feasibility Study: Once the construction project management team has established what materials, equipment and labor are needed, they can estimate costs. Cost estimators use information from past projects, construction drawings and documents such as a bill of quantities to come up with an accurate cost estimate. Then, based on this estimate, a profit margin and financial forecasts will be analyzed to determine if there’s economic feasibility.
• Legal Feasibility Study: Now the company needs to identify all potential regulations, building codes and laws that might affect the project. They’ll need to ask for approval from the local government so that they can begin the construction project .
• Market Feasibility Study: Market feasibility will be determined depending on the nature of the project. For this feasibility example, let’s assume a residential construction project will be built. To gauge market potential, they’ll need to analyze variables such as the average income of the households in the city, crime rate, population density and any trends in state migration.

Manufacturing Feasibility Study

Another industry that uses feasibility studies is manufacturing. It’s a test run of the steps in the manufacturing production cycle to ensure the process is designed properly. Let’s take a look at what a manufacturing feasibility study example would look like.

• Feasibility Study: The first step is to look at various ideas and decide which is the best one to pursue. You don’t want to get started and have to stop. That’s a waste of time, money and effort. Look at what you intend to manufacture, does it fill an unserved need, is the market able to support competition and can you manufacture a quality product on time and within your budget?
• Financial Feasibility Study: Find out if your estimated income from the sale of this product is going to cover your costs, both direct and indirect costs. Work backward from the income you expect to make and the expenses you’ll spend for labor, materials and production to determine if the manufacturing of this product is financially feasible.
• Market Feasibility Study: You’ve already determined that there’s a need that’s not being served, but now it’s time to dig deeper to get realistic projections of revenue. You’ll want to define your target demographic, analyze the competitive landscape, determine the total market volume and what your market share will be and estimate what market expansion opportunities there are.
• Technical Feasibility Study: This is where you’ll explore the production , such as what resources you’ll need to produce your product. These findings will inform your financial feasibility study as well as labor, material, equipment, etc., costs have to be within your budget. You’ll also figure out the processes you’ll use to produce and deliver your product to the market, including warehousing and retail distribution.

There could be other feasibility studies you’ll have to make depending on the product and the market, but these are the essential ones that all manufacturers have to look at before they can make an educated decision as to whether to go forward or abandon the idea.

Best Practices for a Feasibility Study

• Use project management software like ProjectManager to organize your data and work efficiently and effectively
• Use templates or any data and technology that gives you leverage
• Involve the appropriate stakeholders to get their feedback
• Use market research to further your data collection
• Do your homework and ask questions to make sure your data is solid

If your project is feasible, then the real work begins. ProjectManager helps you plan more efficiently. Our online Gantt chart organizes tasks, sets deadlines, adds priority and links dependent tasks to avoid delays. But unlike other Gantt software, we calculate the critical path for you and set a baseline to measure project variance once you move into the execution phase.

Watch a Video on Feasibility Studies

There are many steps and aspects to a project feasibility study. If you want yours to be accurate and forecast correctly whether your project is doable, then you need to have a clear understanding of all its moving parts.

Jennifer Bridges, PMP, is an expert on all aspects of project management and leads this free training video to help you get a firm handle on the subject.

Here’s a screenshot for your reference!

Pro tip: When completing a feasibility study, it’s always good to have a contingency plan that you test to make sure it’s a viable alternative.

ProjectManager Improves Your Feasibility Study

A feasibility study is a project, so get yourself a project management software that can help you execute it. ProjectManager is an award-winning software that can help you manage your feasibility study through every phase.

Once you have a plan for your feasibility study, upload that task list to our software and all your work is populated in our online Gantt chart. Now you can assign tasks to team members, add costs, create timelines, collect all the market research and attach notes at the task level. This gives people a plan to work off of, and a collaborative platform to collect ideas and comments.

If you decide to implement the project, you already have it started in our software, which can now help you monitor and report on its progress. Try it for yourself with this free 30-day trial.

Transcription

Today we’re talking about How to Conduct A Feasibility Study, but first of all, I want to start with clarifying what a feasibility study is.

Feasibility Analysis Definition

Basically, it’s an assessment of the practicality of a proposed plan or method. Basically, we’ll want to want to know, is this feasible. Some of the questions that may generate this or we can hear people asking are, “Do we have or can we create the technology to do this? Do we have the people resource who can produce this and will we get our ROI, our Return On Investment?”

When to Do a Feasibility Study

So when do we do the feasibility study? So it’s done during a project lifecycle and it’s done after the business case because the business case outlines what we’re proposing. Is it a product or service that we’re proposing?

So why do we do this? The reason we do this is that we need to determine the factors that will make the business opportunity a success.

How to Conduct a Feasibility Study

Well, let’s talk about a few steps that we do in order to conduct the feasibility study.

Well, first of all, we conduct a preliminary analysis of what all’s involved in the business case and what we’re analyzing and what we’re trying to determine is feasible.

Then we prepare a projected income statement. We need to know what are the income streams, how are we gonna make money on this. Where’s the revenue coming from? We also need to conduct a market survey.

We need to know, is this a demand? Is there a market for this? Are customers willing to use this product or use this service?

The fourth one is to plan the business organization and operations. What is the structure, what kind of resources do we need? What kind of staffing requirements do we have?

We also want to prepare an opening day balance sheet. What are the…how again, what are the expenses, what’s the revenue and to ensure that being able to determine if we’re gonna make our ROI.

So we want to review and analyze all of the data that we have and with that, we’re going to determine, we’re going to make a go, no-go decision. Meaning, are we going to do this project or this business opportunity or not.

Well, here are some of the best practices to use during your feasibility study.

One is to use templates, tools and surveys that exist today. The great news is, data is becoming more and more prevalent. There are all kinds of technologies. There are groups that they do nothing but research. Things that we can leverage today.

We want to involve the appropriate stakeholders to ensure that input is being considered from the different people involved.

We also want to use again the market research to ensure we’re bringing in good, reliable data.

Do your homework, meaning act like is if this is your project, if it’s your money. So do your homework and do it well and make sure you give credible data.

What Is a Feasibility Report?

So ultimately in the end what we’re doing is, we’re producing and we’re providing a feasibility report. So in that report, think of this is like a template.

So what you’re gonna do is give it an executive summary of the business opportunity that you’re evaluating and the description of the product or the service.

You want to look at different technology considerations. Is it technology that you’re going to use? Are you going to build the technology?

What kind of product and service marketplace and being able again, to identify the specific market you’re going to be targeting? Also, what is the marketing strategy you’re going to use to target the marketplace?

And also what’s the organizational structure? What are the staffing requirements? What people do you need to deliver the product or service and even support it?

So also we want to know the schedule to be able to have the milestones to ensure that as we’re building things, that as we’re spending money that we’re beginning to bring in income to pay and knowing when we’re going to start recuperating some of the funding. Again, which also ties into the financial projections.

Ultimately in this report, you’re going to provide the findings and the recommendations.

Again, we’ll probably talk about technology. Are you going to build it? Are you going to buy it? What are the marketing strategies for the specific marketplace organization? You may have some recommendations for whether you’re going to insource the staff, maybe you are going to outsource some staff and what that looks like and also financial recommendation.

If you’ve been looking for an all-in-one tool that can help with your feasibility study, consider ProjectManager. We offer five project views and countless features that make it seamless to plan projects, organize tasks and stay connected with your team. See what our software can do for you by taking this free 30-day trial.

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• Correspondence
• Open access
• Published: 16 July 2010

What is a pilot or feasibility study? A review of current practice and editorial policy

• Mubashir Arain 1 ,
• Michael J Campbell 1 ,
• Cindy L Cooper 1 &
• Gillian A Lancaster 2  

BMC Medical Research Methodology volume  10 , Article number:  67 ( 2010 ) Cite this article

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In 2004, a review of pilot studies published in seven major medical journals during 2000-01 recommended that the statistical analysis of such studies should be either mainly descriptive or focus on sample size estimation, while results from hypothesis testing must be interpreted with caution. We revisited these journals to see whether the subsequent recommendations have changed the practice of reporting pilot studies. We also conducted a survey to identify the methodological components in registered research studies which are described as 'pilot' or 'feasibility' studies. We extended this survey to grant-awarding bodies and editors of medical journals to discover their policies regarding the function and reporting of pilot studies.

Papers from 2007-08 in seven medical journals were screened to retrieve published pilot studies. Reports of registered and completed studies on the UK Clinical Research Network (UKCRN) Portfolio database were retrieved and scrutinized. Guidance on the conduct and reporting of pilot studies was retrieved from the websites of three grant giving bodies and seven journal editors were canvassed.

54 pilot or feasibility studies published in 2007-8 were found, of which 26 (48%) were pilot studies of interventions and the remainder feasibility studies. The majority incorporated hypothesis-testing (81%), a control arm (69%) and a randomization procedure (62%). Most (81%) pointed towards the need for further research. Only 8 out of 90 pilot studies identified by the earlier review led to subsequent main studies. Twelve studies which were interventional pilot/feasibility studies and which included testing of some component of the research process were identified through the UKCRN Portfolio database. There was no clear distinction in use of the terms 'pilot' and 'feasibility'. Five journal editors replied to our entreaty. In general they were loathe to publish studies described as 'pilot'.

Pilot studies are still poorly reported, with inappropriate emphasis on hypothesis-testing. Authors should be aware of the different requirements of pilot studies, feasibility studies and main studies and report them appropriately. Authors should be explicit as to the purpose of a pilot study. The definitions of feasibility and pilot studies vary and we make proposals here to clarify terminology.

Peer Review reports

A brief definition is that a pilot study is a 'small study for helping to design a further confirmatory study'[ 1 ]. A very useful discussion of exactly what is a pilot study has been given by Thabane et al. [ 2 ] Such kinds of study may have various purposes such as testing study procedures, validity of tools, estimation of the recruitment rate, and estimation of parameters such as the variance of the outcome variable to calculate sample size etc. In pharmacological trials they may be referred to as 'proof of concept' or Phase I or Phase II studies. It has become apparent to us when reviewing research proposals that small studies with all the trappings of a major study, such as randomization and hypothesis testing may be labeled a 'pilot' because they do not have the power to test clinically meaningful hypotheses. The authors of such studies perhaps hope that reviewers will regard a 'pilot' more favourably than a small clinical trial. This lead us to ask when it is legitimate to label a study as a 'pilot' or 'feasibility' study, and what features should be included in these types of studies.

Lancaster et al [ 3 ] conducted a review of seven major medical journals in 2000-1 to produce evidence regarding the components of pilot studies for randomized controlled trials. Their search included both 'pilot' and 'feasibility' studies as keywords. They reported certain recommendations: having clear objectives in a pilot study, inappropriateness of mixing pilot data with main research study, using mainly descriptive statistics obtained and caution regarding the use of hypothesis testing for conclusions. Arnold et al [ 1 ] recently reviewed pilot studies particularly related to critical care medicine by searching the literature from 1997 to 2007. They provided narrative descriptions of some pilot papers particularly those describing critical care medicine procedures. They pointed out that few pilot trials later evolved into subsequent published major trials. They made useful distinctions between: pilot work which is any background research to inform a future study, a pilot study which has specific hypotheses, objectives and methodology and a pilot trial which is a stand-alone pilot study and includes a randomization procedure. They excluded feasibility studies from their consideration.

Thabane et al [ 2 ] gave a checklist of what they think should be included in a pilot study. They included 'feasibility' or 'vanguard' studies but did not distinguish them from pilot studies. They provided a good discussion on how to interpret a pilot study. They stress that not only the outcome or surrogate outcome for the subsequent main study should be described but also that a pilot study should have feasibility outcomes which should be clearly defined and described. Their article was opinion based and not supported by a review of current practice.

The objective of this paper is to provide writers and reviewers of research proposals with evidence from a variety of sources for which components they should expect, and which are unnecessary or unhelpful, in a study which is labeled as a pilot or feasibility study. To do this we repeated Lancaster et al's [ 3 ] review for current papers see if there has been any change in how pilot studies were reported since their study. As many pilot studies are never published we also identified pilot studies which were registered with the UK Clinical Research Network (UKCRN) Portfolio Database. This aims to be a "complete picture of the clinical research which is currently taking place across the UK". All studies included have to have been peer reviewed through a formal independent process. We examined the websites of some grant giving bodies to find their definition of a pilot study and their funding policy toward them. Finally we contacted editors of leading medical journals to discover their policy of accepting studies described as 'pilot' or 'feasibility'.

Literature survey

MEDLINE, Web of Science and university library data bases were searched for the years 2007-8 using the same key words "Pilot" or "Feasibility" as used by Lancaster et al. [ 3 ]. We reviewed the same four general medicine journals: the British Medical Journal (BMJ), Lancet, the New England Journal of Medicine (NEJM) and the Journal of American Medical Association (JAMA) and the same three specialist journals: British Journal of Surgery (BJS), British Journal of Cancer (BJC), British Journal of Obstetrics and Gynecology (BJOG). We excluded review papers. The full text of the relevant papers was obtained. GL reviewed 20 papers and classified them into groups as described in her original paper [ 3 ]. Subsequently MA, in discussion with MC, designed a data extraction form to classify the papers. We changed one category from GL's original paper. We separated the category 'Phase I/II trials' from the 'Piloting new treatment, technique, combination of treatments' category. We then classified the remaining paper into the categories described in Table 1 . The total number of research papers by journal was obtained by searching journal article with abstracts (excluding reviews) using Pubmed. We searched citations to see whether the pilot studies identified by Lancaster et al [ 3 ] eventually led to main trials.

Portfolio database review

The (UKCRN) Portfolio Database was searched for the terms 'feasibility' or 'pilot' in the title or research summary. Duplicate cases and studies classified as 'observational' were omitted. From the remaining studies those classified as 'closed' were selected to exclude studies which may not have started or progressed. Data were extracted directly from the research summary of the database or where that was insufficient the principle investigator was contacted for related publications or study protocols.

Editor and funding agency survey

We wrote to the seven medical journal editors of the same journals used by Lancaster et al. [ 3 ], (BMJ, Lancet, NEJM, JAMA. BJS, BJC and BJOG) and looked at the policies of three funding agencies (British Medical Research Council, Research for Patient Benefit and NETSCC (National Institute for Health Research Trials and Studies Coordinating Centre). We wished to explore whether there was any specified policy of the journal for publishing pilot trials and how the editors defined a pilot study. We also wished to see if there was funding for pilot studies.

Initially 77 papers were found in the target journals for 2007-8 but 23 were review papers or commentaries or indirectly referred to the word "pilot" or "feasibility" and were not actually pilot studies leaving a total of 54 papers. Table 1 shows the results by journal and by type of study and also shows the numbers reported by Lancaster et al. [ 3 ] for 2000-01 in the same medical journals. There was a decrease in the proportion of pilot studies published over the period of time, however the difference was not statistically significant (2.0% vs 1.6%; X 2 = 1.6, P = 0.2). It is noticeable that the Phase I or Phase II studies are largely confined to the cancer journals.

Lancaster et al [ 3 ] found that 50% of pilot studies reported the intention of further work yet we identified only 8 (8.8%) which were followed up by a major study. Of these 2 (25%) were published in the same journal as the pilot.

Twenty-six of the studies found in 2007-8 were described as pilot or feasibility studies for randomized clinical trials (RCTs) including Phase II studies. Table 2 gives the numbers of studies which describe specific components of RCTs. Sample size calculations were performed and reported in 9 (36%) of the studies. Hypothesis testing and performing inferential statistics to report significant results was observed in 21 (81%) of pilot studies. The processes of blinding was observed in only 5 (20%) although the randomization procedure was applied or tested in 16 (62%) studies. Similarly a control group was assigned in most of the studies (n = 18; 69%). As many as 21 (81%) of pilot studies suggested the need for further investigation of the tested drug or procedure and did not report conclusive results on the basis of their pilot data. The median number of participants was 76, inter-quartile range (42, 216).

Of the 54 studies in 2007-8, a total of 20 were described as 'pilot' and 34 were described as 'feasibility' studies. Table 3 contrasts those which were identified by the keyword 'pilot' with those identified by 'feasibility'. Those using 'pilot' were more likely to have a pre-study sample size estimate, to use randomization and to use a control group. In the 'pilot' group 16(80%) suggested further study, in contrast to 15 (44%) in the 'feasibility' group.

A total of 34 studies were identified using the term 'feasibility' or 'pilot' in the title or research summary which were prospective interventional studies and were closed, i.e. not currently running and available for analysis. Only 12 studies were interventional pilot/feasibility studies which included testing of some component of the research process. Of these 5 were referred to as 'feasibility', 6 as 'pilot' and 1 as both 'feasibility' and 'pilot' (Table 4 ).

The methodological components tested within these studies were: estimation of sample size; number of subjects eligible; resources (e.g. cost), time scale; population-related (e.g. exclusion criteria), randomisation process/acceptability; data collection systems/forms; outcome measures; follow-up (response rates, adherence); overall design; whole trial feasibility. In addition to one or more of these, some studies also looked at clinical outcomes including: feasibility/acceptability of intervention; dose, efficacy and safety of intervention.

The results are shown in Table 4 . Pilot studies alone included estimation of sample size for a future bigger study and tested a greater number of components in each study. The majority of the pilots and the feasibility studies ran the whole study 'in miniature' as it would be in the full study, with or without randomization.

As an example of a pilot study consider 'CHOICES: A pilot patient preference randomised controlled trial of admission to a Women's Crisis House compared with psychiatric hospital admissions' http://www.iop.kcl.ac.uk/projects/default.aspx?id=10290 . This study looked at multiple components of a potential bigger study. It aimed to determine the proportion of women unwilling to be randomised, the feasibility of a patient preference RCT design, the outcome and cost measures to determine which outcome measures to use, the recruitment and drop out rates; and to estimate the levels of outcome variability to calculate sample sizes for the main study. It also intended to develop a user focused and designed instrument which is the outcome from the study. The sample size was 70.

The editors of five (out of seven) medical journals responded to our request for information regarding publishing policy for pilot studies. Four of the journals did not have a specified policy about publishing pilot studies and mostly reported that pilot trials cannot be published if the standard is lower than a full clinical trial requirement. The Lancet has started creating space for preliminary phase I trials and set a different standard for preliminary studies. Most of the other journals do not encourage the publication of pilot studies because they consider them less rigorous than main studies. Nevertheless some editors accepted pilot studies for publication by compromising only on the requirement for a pre-study sample size calculation. All other methodological issued were considered as important as for the full trials, such as trial registration, randomization, hypothesis testing, statistical analysis and reporting according to the CONSORT guidelines.

All three funding bodies made a point to note that pilot and feasibility studies would be considered for funding. Thabane et al [ 2 ] provided a list of websites which define pilot or feasibility studies. We considered the NETSCC definition to be most helpful and to most closely mirror what investigators are doing and it is given below.

NETSCC definition of pilot and feasibility studies http://www.netscc.ac.uk/glossary/

Feasibility Studies

Feasibility Studies are pieces of research done before a main study. They are used to estimate important parameters that are needed to design the main study. For instance:

standard deviation of the outcome measure, which is needed in some cases to estimate sample size,

willingness of participants to be randomised,

willingness of clinicians to recruit participants,

number of eligible patients,

characteristics of the proposed outcome measure and in some cases feasibility studies might involve designing a suitable outcome measure,

follow-up rates, response rates to questionnaires, adherence/compliance rates, ICCs in cluster trials, etc.

Feasibility studies for randomised controlled trials may not themselves be randomised. Crucially, feasibility studies do not evaluate the outcome of interest; that is left to the main study.

If a feasibility study is a small randomised controlled trial, it need not have a primary outcome and the usual sort of power calculation is not normally undertaken. Instead the sample size should be adequate to estimate the critical parameters (e.g. recruitment rate) to the necessary degree of precision.

Pilot studies

A Pilot Study is a version of the main study that is run in miniature to test whether the components of the main study can all work together. It is focused on the processes of the main study, for example to ensure recruitment, randomisation, treatment, and follow-up assessments all run smoothly. It will therefore resemble the main study in many respects. In some cases this will be the first phase of the substantive study and data from the pilot phase may contribute to the final analysis; this can be referred to as an internal pilot. Alternatively at the end of the pilot study the data may be analysed and set aside, a so-called external pilot.

In our repeat of Lancaster et al's study [ 3 ] we found that the reporting of pilot studies was still poor. It is generally accepted that small, underpowered clinical trials are unethical [ 4 ]. Thus it is not an excuse to label such a study as a pilot and hope to make it ethical. We have shown that pilot studies have different objectives to RCTs and these should be clearly described. Participants in such studies should be informed that they are in a pilot study and that there may not be a further larger study.

It is helpful to make a more formal distinction between a 'pilot' and a 'feasibility' study. We found that studies labeled 'feasibility' were conducted with more flexible methodology compared to those labeled 'pilot'. For example the term 'feasibility' has been used for large scale studies such as a screening programme applied at a population level to determine the initial feasibility of the programme. On the other hand 'pilot' studies were reported with more rigorous methodological components like sample size estimation, randomization and control group selection than studies labeled 'feasibility'. We found the NETSCC definition to be the most helpful since it distinguishes between these types of study.

In addition it was observed that most of the pilot studies report their results as inconclusive, with the intention of conducting a further, larger study. In contrast, several of the feasibility studies did not admit such an intention. On the basis of their intention one would have expected about 45 of the studies identified by Lancaster et al in 2000/1 to have been followed by a bigger study whereas we only found 8. This would reflect the opinion of most of the journal editors and experts who responded to our survey, who felt that pilot studies rarely act as a precursor for a bigger study. The main reason given was that if the pilot shows significant results then researchers may not find it necessary to conduct the main trial. In addition if the results are unfavorable or the authors find an unfeasible procedure, the main study is less likely to be considered useful. Our limited review of funding bodies was encouraging. Certainly when reviewing grant applications, we have found it helpful to have the results of a pilot study included in the bid. We think that authors of pilots studies should be explicit as to their purpose, e.g. to test a new procedure in preparation for a clinical trial. We also think that authors of proposals for pilot studies should be more explicit as to the criteria which lead to further studies being abandoned, and that this should be an important part of the proposal.

In the Portfolio Database review, only pilot studies cited an intention to estimate sample size calculations for future studies and the majority of pilot studies were full studies run with smaller sample sizes to test out a number of methodological components and clinical outcomes simultaneously. In comparison the feasibility studies tended to focus on fewer methodological components within individual studies. For example, the 6 pilot studies reported the intention to evaluate a total of 17 methodological components whereas in the 5 feasibility studies a total of only 6 methodological components were specifically identified as being under investigation (Table 4 ). However, both pilot and feasibility studies included trials run as complete studies, including randomization, but with sample sizes smaller than would be intended in the full study and the distinction between the two terms was not clear-cut.

Another reason for conducting a pilot study is to provide information to enable a sample size calculation in a subsequent main study. However since pilot studies tend to be small, the results should be interpreted with caution [ 5 ]. Only a small proportion of published pilot studies reported pre-study sample size calculations. Most journal editors reported that a sample size calculation is not a mandatory criterion for publishing pilot studies and suggested that it should not be done.

Some authors suggest that analysis of pilot studies should mainly be descriptive,[ 3 , 6 ] as hypothesis testing requires a powered sample size which is usually not available in pilot studies. In addition, inferential statistics and testing hypothesis for effectiveness require a control arm which may not be present in all pilot studies. However most of the pilot interventional studies in this review contained a control group and the authors performed and reported hypothesis testing for one or more variables. Some tested the effectiveness of an intervention and others just performed statistical testing to discover any important associations in the study variables. Observed practice is not necessarily good practice and we concur with Thabane et al [ 2 ] that any testing of an intervention needs to be reported cautiously.

The views of the journal editors, albeit from a small sample, were not particularly encouraging and reflected the experience of Lancaster et al [ 3 ]. Pilot studies, by their nature, will not produce 'significant' (i.e P < 0.05) results. We believe that publishing the results of well conducted pilot or feasibility studies is important for research, irrespective of outcome.. There is an increasing awareness that publishing only 'significant' results can lead to considerably error [ 7 ]. The journals we considered were all established, paper journals and perhaps the newer electronic journals will be more willing to consider the publication of the results from these types of studies.

We may expect that trials will increasingly be used to evaluate 'complex interventions'[ 8 , 9 ]. The MRC guidelines [ 8 ] explicitly suggest that preliminary studies, including pilots, be used prior to any major trial which seeks to evaluate a package of interventions (such as an educational course), rather than a single intervention (such as a drug). Thus it is likely that reviewers will be increasingly asked to pronounce on these and will require guidance as to how to review them.

Conclusions

We conclude that pilot studies are still poorly reported, with inappropriate emphasis on hypothesis-testing. We believe authors should be aware of the different requirements of pilot studies and feasibility studies and report them appropriately. We found that in practice the definitions of feasibility and pilot studies are not distinct and vary between health research funding bodies and we suggest use of the NETSCC definition to clarify terminology.

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MA reviewed the papers of 2000/1 and those of 2007/8 under the supervision of MC and helped to draft the manuscript. MC conceived of the study, and participated in its design and coordination and drafted the manuscript. CC conducted the portfolio database study and commented on the manuscript. GA conducted the original study, reviewed 20 papers and commented on the manuscript. All authors read and approved the final manuscript.

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Arain, M., Campbell, M.J., Cooper, C.L. et al. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol 10 , 67 (2010). https://doi.org/10.1186/1471-2288-10-67

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Make It So: How to Conduct a Feasibility Study for Better Project Planning

Lucid Content

Reading time: about 7 min

The most successful companies have ambitious goals. Whether you’re launching a new product or delving into a new market, growth requires some level of testing and risk. Sometimes, it means taking on projects or initiatives without knowing exactly how it will come to life or whether it will ultimately benefit the business.

Still, successful business leaders know that time and resources are the most valuable assets for any company. And smart project managers work to make sure both are being maximized for the good of the business. Understanding the feasibility and potential ROI on a project before it ever gets started will not only help you make the most of your time—but maximize your business results. 

Determining feasibility 

This is the initiation stage of the project management lifecycle. At this stage, you determine your objectives, identify your major project deliverables, and decide whether the project can reasonably be completed with good results. This is where a feasibility study comes into play.

What is a feasibility study? 

Simply put, a feasibility study is an assessment of the practicality of a proposed plan or method. Just as the name implies, the study answers the question, “Is this project feasible?” 

To determine this, start by answering the who, what, when, when, and how of your project. Conduct an analysis to determine who needs to be involved in the project , what needs to be done, when it needs to be completed, and how everything will come together to make the project successful. This process of evaluation is at the core of a feasibility study, a common process to complete when results are uncertain and stakes are high.

Feasibility study example: Company A is looking to invest in a new software-as-a-service (SaaS) solution. First, the stakeholders in the investment will analyze what technology or workflow problem the investment will address. The team will also take contractual or subscription costs into account, plus what resources will be required for training and implementation. The study may also need to gauge what kind of change management will be required to gain buy-in. Those conducting the study evaluate all the project data, as well as pros and cons. Finally, they can make an informed decision on whether the investment is a go. 

Types of feasibility studies

There are five types of feasibility studies, each of which provides a different lens to help you evaluate whether your business idea or project is viable: 

1. Economic feasibility

When budgets are at play, it’s important to determine whether the investment will be worth it. Simply put, will your project be profitable? With an economic feasibility study, you run a cost-benefit analysis to determine how much value the project will bring to the business.

2. Technical feasibility

This broad concept can be applied to many types of projects, from software development to construction. Validate the technical resources and capabilities needed to convert the ideas into a working project or system.

3. Operational feasibility

Even the most strategic, well-intentioned projects can go astray if they’re too difficult to bring together, or don’t directly address or solve the problem at hand. An operational analysis helps you understand how well the proposed project will address the problem. 

4. Schedule feasibility

Also referred to as time visibility, this type of feasibility study can help you determine how reasonable the project’s timeline is when measured against existing projects and available resources. Proper evaluation at this step can also help you avoid unpredictable or extra costs. 

5. Legal feasibility

Legal feasibility analysis helps you understand if your proposed plan conforms to legal and ethical requirements. These requirements may include zoning laws, data protection acts, or privacy laws. 

How to conduct a feasibility study

Think about the last time you needed to solve a problem—either at home or at work. If it was a familiar problem, you likely already had a previous experience or game plan to guide your progress. New types of problems or circumstances, however, require new, creative ways of thinking and innovative solutions. 

When determining how to approach a business need, problem, or opportunity, it’s important to determine whether your plan of attack is feasible, and what steps needed to be taken to be successful. But how do you separate a feasible project from a misguided one? 

Here are seven steps to determine if your project is feasible: 

1. Analyze the problem

First, conduct a preliminary analysis of project requirements to assess the practicality and viability of the proposed plan. Do you have the technology and resources required to get the project off the ground? How will you measure and determine the ROI of the project? Understanding your business goals and objectives before you start the project will help keep everyone aligned and working toward the same goal. 

2. Evaluate the budget

The quickest way to derail any new project or initiative is to misuse or waste budget. Especially when budgets are limited, your stakeholders want to know whether the money you spend will make a difference to the bottom line. Determine how much budget you have available for the project—and identify the projected revenue streams. How will this project result in a monetary return on investment?

3. Do your research

Next, take a deeper look at the market. Is there a demand for your product or business plan? For smaller projects, what roadblocks will you face along the way? What are your competitors doing? If your project goals are too narrow, or they don’t align to larger business goals, it might be wise to reevaluate your approach. 

4. Make a plan

Armed with your research, create an action plan to bring your project to life. What resources—people, processes, and tech—will you need to complete the project? A work breakdown structure (WBS) , which breaks down projects into smaller, more manageable pieces that you can reasonably evaluate and assign to teams, can be used to build this plan. 

There are plenty of diagrams available to better manage a project. Similar to a WBS, Program, Evaluation, and Review Technique (PERT) charts and Gantt charts can be used to break projects into smaller more digestible tasks to determine how long each step of the project will take. A PERT chart better illustrates the interdependency between project tasks, while a Gantt chart helps you visualize progress on a project as it’s happening. 

5. Make a balance sheet

Now that you have an actionable plan in hand, it’s time to reevaluate the finances of the project. To do this, bring in financial data to prepare a project kickoff balance sheet. Are you still projecting the same revenue? 

6. Check your data

It’s crunch time. Before you decide whether it makes sense to move forward with the project, take another look at all the data at your fingertips. Objectively, how likely is it that this project will be successful? 

7. Decide what’s next

With all of these evaluations in place, you’ll be able to confidently, objectively, and strategically determine whether the project is feasible. If it’s not, you can build a more thoughtful, strategic plan to run through a feasibility study. If all signs point to “yes,” it’s time to give your project the green light. 

Business moves fast, and for many businesses, it can be tempting to skip evaluation stages in order to get projects done more quickly. Too often, however, this leads to misalignment, derailed projects, duplicative work—or even worse, wasted time and budget. No matter your industry, a feasibility study can help you surface risks and uncertainties and increase your odds of business success. 

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Lucidchart, a cloud-based intelligent diagramming application, is a core component of Lucid Software's Visual Collaboration Suite. This intuitive, cloud-based solution empowers teams to collaborate in real-time to build flowcharts, mockups, UML diagrams, customer journey maps, and more. Lucidchart propels teams forward to build the future faster. Lucid is proud to serve top businesses around the world, including customers such as Google, GE, and NBC Universal, and 99% of the Fortune 500. Lucid partners with industry leaders, including Google, Atlassian, and Microsoft. Since its founding, Lucid has received numerous awards for its products, business, and workplace culture. For more information, visit lucidchart.com.

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What's the difference between a PERT chart and a Gantt chart? Both of these tools can improve your project management processes. Learn when to use PERT and Gantt charts and how to create them.

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Learn about the 4 phases of the project management life cycle. Whether you’re working on a small project or a large, multi-departmental initiative, you can apply our tips to successfully take your projects from initiation to close.

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• Published: 17 April 2014

A feasibility study testing four hypotheses with phase II outcomes in advanced colorectal cancer (MRC FOCUS3): a model for randomised controlled trials in the era of personalised medicine?

• T S Maughan 1 ,
• A M Meade 2 ,
• R A Adams 3 ,
• S D Richman 4 ,
• R Butler 5 ,
• D Fisher 2 ,
• R H Wilson 6 ,
• B Jasani 7 ,
• G R Taylor 4 ,
• G T Williams 7 ,
• J R Sampson 7 ,
• M T Seymour 8 ,
• L L Nichols 2 ,
• S L Kenny 2 ,
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• E Hodgkinson 10 ,
• J A Bridgewater 11 ,
• D L Furniss 10 ,
• M J Pope 2   na1 ,
• J K Pope 2   na1 ,
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• R Kaplan 2  

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This article has been updated

Background:

Molecular characteristics of cancer vary between individuals. In future, most trials will require assessment of biomarkers to allocate patients into enriched populations in which targeted therapies are more likely to be effective. The MRC FOCUS3 trial is a feasibility study to assess key elements in the planning of such studies.

Patients and Methods:

Patients with advanced colorectal cancer were registered from 24 centres between February 2010 and April 2011. With their consent, patients’ tumour samples were analysed for KRAS/BRAF oncogene mutation status and topoisomerase 1 (topo-1) immunohistochemistry. Patients were then classified into one of four molecular strata; within each strata patients were randomised to one of two hypothesis-driven experimental therapies or a common control arm (FOLFIRI chemotherapy). A 4-stage suite of patient information sheets (PISs) was developed to avoid patient overload.

A total of 332 patients were registered, 244 randomised. Among randomised patients, biomarker results were provided within 10 working days (w.d.) in 71%, 15 w.d. in 91% and 20 w.d. in 99%. DNA mutation analysis was 100% concordant between two laboratories. Over 90% of participants reported excellent understanding of all aspects of the trial. In this randomised phase II setting, omission of irinotecan in the low topo-1 group was associated with increased response rate and addition of cetuximab in the KRAS, BRAF wild-type cohort was associated with longer progression-free survival.

Conclusions:

Patient samples can be collected and analysed within workable time frames and with reproducible mutation results. Complex multi-arm designs are acceptable to patients with good PIS. Randomisation within each cohort provides outcome data that can inform clinical practice.

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Fluoropyrimidine type, patient age, tumour sidedness and mutation status as determinants of benefit in patients with metastatic colorectal cancer treated with EGFR monoclonal antibodies: individual patient data pooled analysis of randomised trials from the ARCAD database

Critical evaluation of molecular tumour board outcomes following 2 years of clinical practice in a Comprehensive Cancer Centre

Cancer is the product of a somatic evolutionary process, in which successive advantageous genetic and epigenetic alterations drive the progression of the disease ( Greaves and Maley, 2012 ). Although current knowledge indicates many similar changes in different cancers, the number of possible combinations of changes even within a given anatomical/histological type such as colorectal cancer (CRC) is very large ( The Cancer Genome Network Atlas, 2012 ). This raises a major challenge in the search for effective therapies that target the properties of any given cancer, especially for advanced disease where clonal evolution and the selective pressure of prior therapies drive increasing diversity and resistance to subsequent therapy ( Sequist et al, 2011 ; Gerlinger et al, 2012 ). This emerging understanding of the heterogeneity of cancer is a major challenge to clinical trialists and demands new methodologies for testing novel therapies.

Fundamental to this challenge is the identification of biomarkers that help enrich the evaluated population for benefit from a specific therapy. In CRC, the use of epidermal growth factor receptor (EGFR)-targeted therapy has led to the discovery of the importance of KRAS and recently NRAS mutations ( Douillard et al, 2013 ) in prediction of lack of response to that therapy and association of BRAF mutation with a particularly poor prognosis in advanced CRC (ACRC; Lievre et al, 2006 ; Karapetis et al, 2008 ; Maughan et al, 2011 ). Further biomarker candidates under evaluation as potentially predicting lack of benefit from anti-EGFR therapy are PI3K mutations and loss of PTEN expression ( De Roock et al, 2010 ; Seymour et al, 2013 ).

This paper reports the results of the MRC FOCUS3 trial (ISRCTN83171665), a randomised feasibility trial for the selection of therapy for patients with ACRC based on their KRAS and BRAF mutation status as well as their topoisomerase 1 (topo-1) expression status.

Materials and Methods

Trial design.

Patients were registered on the day they provided written consent for the release of a tumour sample. Upon determination of their biomarker status, patients were allocated to one of four molecular subgroups for randomisation: (1) low topo-1 expression levels and both KRAS and BRAF wild type, (2) low topo-1 and either KRAS- or BRAF -activating mutations, (3) high topo-1 and both KRAS and BRAF wild type and (4) high topo-1 and either KRAS or BRAF mutations. These randomisation subgroups correspond to the prior hypotheses that: (1) in patients with low topo-1 tumours, FU alone is similarly effective and therefore preferable to irinotecan/FU combination ( Braun et al, 2008 ); (2) in patients with KRAS/BRAF wild-type tumours, anti-EGFR therapy improves outcomes ( Van Cutsem et al, 2009 ); (3) in patients with high topo-1 tumours, addition of oxaliplatin to irinotecan/FU improves outcomes ( Braun et al, 2008 ) and (4) in patients with KRAS/BRAF-mutated tumours, anti-VEGF therapy might improve outcomes. There was no specific rationale for a biologically targeted therapy in patients with KRAS mutations; however, there were data suggesting benefit of bevacizumab ( Ince et al, 2005 ).

Patients were randomised centrally by the MRC CTU via telephone using minimisation and allocated in a 1 : 1 : 1 ratio to the control arm (A) common to each of the four subgroups or one of two experimental regimens ( Figures 1 and 2 ). If either molecular test failed, patients could still be randomised in a 1 : 1 ratio based on the results available ( Figure 1 ). Treatment allocation was not masked. Randomisation was stratified by standard clinical prognostic factors.

Trial design.

Diagram in patient information sheet 1 – given to patients to explain the tests carried out on their tumour sample.

Eligibility criteria were age ⩾ 18 years, colorectal adenocarcinoma, inoperable metastatic or locoregional RECIST measurable disease, no previous chemotherapy for metastases, WHO performance status 0–2 and good organ function ( Maughan and Meade, 2010 ). Written informed consent for both molecular testing and randomisation was required.

Outcome measures and sample size

The primary outcome measures for FOCUS3 were process outcomes, namely, in this national multi-site setting, how frequently the target could be met of ⩽ 10 w.d. between the date of registration and: (1) the provision of results to the investigator and (2) randomisation.

The target sample size was 240 patients; if >226 tumour blocks were processed within 10 w.d., we could reliably state that ⩾ 90% samples could be analysed within that time frame. If <206 blocks were processed within 10 w.d., we could reliably exclude a turnaround rate of 90% (i.e., the upper 95% confidence limit would exclude 90%).

Secondary outcome measures included toxicity, response rates (RRs) and progression-free survival (PFS) of the different regimens within each molecular subgroup; reproducibility of biomarker results and attitudes of patients to the study design, the consent process and refusal rates for trial entry.

Informed consent and patients attitudes to the trial design

A staged set of patient information sheets (PISs) was developed with input from patients, carers and nursing staff: PIS 1 explained the need for further analyses of tumour tissue using a very simple diagram and no technical details (see Figure 2 ), PIS2, given to patients before results of their molecular tests were known, covered the general issues of a three arm RCT and treatment side-effects. PIS3, in four specific versions a–d, describing the three arm randomisation for each of the four molecular sub-types (1–4) was given to patients before randomisation. PIS4, versions a–e, contained full details of the five treatment regimens (A–E).

Patient understanding of the information was captured on a questionnaire delivered immediately following their reading of the stage 2 PIS.

Attitudes of participants to trial entry, understanding and experience, particularly to the proposed 2 weeks time for tumour testing before treatment allocation, were evaluated by one-to-one semi-structured interviews using interpretative phenomenological analysis in a subgroup of randomised patients ( Smith and Osborn, 2003 ).

Sample collection and analysis process

The clinical research nurse (CRN) at the recruiting hospital requested the patients’ diagnostic FFPE block. Histopathology agreements were in place between MRC and all diagnostic hospitals outlining the trial rationale and stressing the importance of sending blocks promptly to the central laboratories. The MRC CTU team actively tracked samples throughout the biomarker analysis process. Upon reconfirmation of eligibility, and with their consent, patients were randomised.

Biomarker analysis

Analysis of DNA extracted from macro-dissected FFPE sections of KRAS codons 12, 13 and 61 and BRAF codon 600 was each performed by Pyrosequencing (details in Supplementary Appendix ).

Topo-1 protein expression was identified using a topo-1 antibody (NCL-TOPO1; Leica, Wetzlar, Germany; details in Supplementary Appendix ). Each case was scored on the basis of the percentage of positive tumour cells (<10% scored low, >10% high).

Quality assurance of biomarker analysis

Fifty samples were blinded and exchanged between the two laboratories before the trial and analysed for KRAS and BRAF mutation status. Throughout the trial both laboratories took part in external quality assessment (UK NEQAS) for KRAS . Topo-1 IHC was compared between laboratories.

Interventions and assessments

The five treatment regimens were all based on the 2-weekly FOLFIRI regimen – folinic acid and irinotecan followed by bolus and infusional 5-fluouracil (5-FU; Douillard et al, 2000 ): (A) Control: FOLFIRI, (B) omits irinotecan: LV5FU2, (C) adds oxaliplatin: FOLFOXIRI (FOLFIRI and oxaliplatin), (D) FOLFIRI plus cetuximab and (E) FOLFIRI plus bevacizumab. Doses in (C) were dependent on patient age and WHO performance status. The chemotherapy regimens FOLFIRI and LV5FU2 are internationally recognised acronyms. The actual regimens used in FOCUS3 were established in the UK ( Cheeseman et al, 2002 ; Leonard et al, 2002 ). They have been used in large numbers of patients, have been shown to be both efficacious and safe ( Seymour et al, 2007 ) and will be referred to as FOLFIRI and LV5FU2 in this paper. The FOLFIRI regimen consisted of an IV infusion of 180 mg m −2 IV infusion over 30 min followed by 350 mg IV infusion d,l-folinic acid or 175 mg l-folinic acid over 2 h. A 400 mg m −2 IV bolus injection of 5-FU was then administered over 5 min followed by 2400 mg m −2 5-flurouracil IV infusion over 46 h. For the LV5FU2 regimen, irinotecan was omitted and the 5-fluourouracil IV infusion dose was increased to 2800 mg m −2 . There were three different FOLFOXIRI regimens, which were prescribed based on the patient’s age and WHO PS status. The regimen for patients aged 70 years or less and with PS=0–1 contained 180 mg m −2 irinotecan and 85 mg m −2 oxaliplatin, 400 mg m −2 5-fluorouracil bolus and 2400 mg m −2 5-fluorouracil infusion. The individual components were reduced to 80% of full dose for patients ⩾ 70 years or PS=2 and to 60% for patients ⩾ 70 years and PS=2. In arm D, cetuximab was administered before chemotherapy as an IV dose of 500 mg m −2 , whereas in arm E bevacizumab was administered first as a 5 mg kg −1 IV infusion. All of the regimens are described in detail in the FOCUS 3 protocol ( Maughan and Meade, 2010 ).

If molecular results were not confirmed by 2 weeks, patients could have one cycle of LV5FU2 before randomisation. Treatment continued for at least 24 weeks or until disease progression on treatment.

Patient symptoms were scored using National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0. SAEs and deaths, together with an assessment of causality, were continuously reported; and were reassessed by an experienced oncologist on behalf of the MRC.

CT scans were performed within 5 weeks before the start of treatment and then 12 weekly on treatment and evaluated using RECIST (v1.1) criteria. Responses were not confirmed by repeat scans and external radiological review was not undertaken.

Statistical methods

Analyses were conducted according to a predefined statistical analysis plan, which was approved by the FOCUS3 TMG before database lock (first analysed in August 2011, data updated for final analysis in May 2012).

For each of the co-primary process outcomes, an exact binomial 95% confidence interval was calculated around the result. Exploratory analyses of the efficacy end points were planned in relation to the four hypotheses stated above (Trial Design), which in each case involved factorial analysis of two relevant molecular subgroups, as illustrated in Figure 1 . Time-to-event curves for analysis of PFS were estimated using the Kaplan–Meier method. All statistical analyses were carried out using Stata version 12 (StataCorp, College Station, TX, USA).

Between February 2010 and April 2011, 332 patients from 24 centres in the UK were registered for the FOCUS3 trial.

Topo-1 status was determined in 306 patients (92%) and was highly expressed (2–3) in 244 (73%). KRAS and BRAF status were determined in 319 patients (96%), of whom 117 (37%) had a KRAS mutation alone, 25 (8%) BRAF mutation alone, 1 (<1%) both mutations, 169 (53%) were double wild type and 7 (2%) had a BRAF mutation but inconclusive KRAS status. No association was seen between topo-1 expression and KRAS / BRAF mutation status ( Table 1 ).

Of patients registered, 288 were eligible for randomisation, and ultimately 244 (85%) were randomised. The reasons why patients were not randomised are described in Figure 3 (Consort Diagram). The main baseline characteristics and treatment allocation of all randomised patients are shown in Table 2 (and in Supplementary Tables 1 and 2 ) and Figure 3 . The distribution of KRAS/BRAF and Topo-1 status both at registration and randomisation is shown in Table 1 .

CONSORT diagram.

Primary process outcomes

The two co-primary process outcome measures were not met. Of those patients randomised 180 (74%) had their biomarker results within 10 w.d. of registration (95% CI=68%, 79%). However, the results for 225 patients (92%) were available to investigators within 15 w.d. of randomisation (95% CI=88%, 95%). The interval between registration and randomisation was less than or equal to 10 w.d. in only 70 (29%) patients (95% CI=23%, 35%), which suggests delays due to clinical issues (such as visit scheduling after results were available) had a greater impact on timelines than delays in biomarker analysis ( Supplementary Table 3 ).

Reproducibility of biomarker results

100% concordance was achieved in the DNA mutation analysis results obtained between the two reference laboratories. Initial crossing over of topo-1 samples between the laboratories produced consistent results, although there were a higher proportion of ‘high’ expressing tumours than was observed in FOCUS. The Cardiff centre was not able to fully adopt the previously validated Leeds laboratory topo-1 protocol, and early in the trial it was realised that the protocols adopted at the two centres were not giving uniformly consistent results required for trial purposes. All subsequent sample testing for KRAS , BRAF and topo-1 was therefore performed at Leeds.

Patient understanding

In all, 90–95% of participants self-reported that they either fully or mostly understood all of the aspects of the trial, see Figure 4 . The areas that were least well understood were the need to wait 2 weeks before start of treatment, how treatment was allocated and what happens during treatment.

Patient understanding of the consent process. Q1: Understanding of PIS2. Q2: Understanding why tumour was tested. Q3: Understanding of different treatments. Q4: Understanding of why you had to wait 2 weeks. Q5: Understanding of how treatment was allocated. Q6: Understanding of what happens during treatment. Q7: Understanding of request to give blood, complete questionnaire, take part in an interview.

Qualitative research

In-depth, interviews with 14 randomised patients were analysed using interpretative phenomenological analysis and will be published in full elsewhere. The dominant issue for the majority of participants was that they were discussing the trial immediately following diagnosis of ACRC. This was a greater concern than trial entry itself. Two of the fourteen interviewees experienced delays with results from tumour testing, causing significant distress. The majority of patients expressed no concern with tumour testing times but highlighted distress caused by prior delays during diagnosis and treatment.

Relationships with family were key to ongoing practical and emotional support and particularly relevant to the decision to enrol on the trial and the processing of information. The multiple roles of the CRN emerged in relation to recruitment and the ongoing care of participants in the trial. Reasons for enrolling in FOCUS3 related to altruism, perception of the trial as offering personalised treatment and better care, finding a cure for cancer and being the only option available.

Treatment and follow-up

Of the 244 randomised patients, 4 did not commence treatment—2 from arm A and 2 from arm E. Of the remaining 240, two patients (0.8%) received a single initial cycle of LV5FU2 alone before commencing their allocated regimens. Full-dose FOLFOXIRI was initiated in the 86% of patients with high topo-1 who were <70 and PFS 0–1; the remainder commenced at lower doses as per protocol. The median number of cycles of treatment delivered was 12 (IQR=7–13).

Efficacy outcomes

Efficacy outcomes were assessed in May 2012 when the median duration of follow-up was 15.2 months (IQR=12.6–18.8 months).

In patients with low topo-1 (B vs A, n =30), 12-week RR was 60% with LV5FU2 alone and 47% with FOLFIRI, supporting the original hypothesis that irinotecan does not add benefit in this group. There was no evidence of a difference in PFS.

There was no improvement in RR (40% vs 45%) or in PFS (HR=1.08 (0.67–1.76)) with the addition of oxaliplatin ( n =127) to FOLFIRI (C vs A). The complex randomisation algorithm resulted in a gender imbalance with more males in this group, which has uncertain relevance.

In patients with KRAS and BRAF wild type (D vs A, n =92), the addition of cetuximab to FOLFIRI was associated with an increased RR (44% vs 66%) and PFS (HR=0.44 (0.23–0.82)), consistent with the results of the phase III Crystal trial ( Van Cutsem et al, 2009 , 2011 ).

For the addition of bevacizumab to FOLFIRI in patients with KRAS or BRAF mutations (E vs A, n =72), there was an observed increased RR (47% vs 33%). No PFS benefits were observed.

Kaplan–Meier survival curves are presented in Figure 5 and 12-week RR data are summarised in Table 3 .

Treatment comparisons – progression-free survival.

Toxicity observed was as expected for the LV5FU2, FOLFIRI, FOLFIRI+cetuximab and FOLFIRI+bevacizumab regimens. The anticipated increased toxicity of the FOLFOXIRI regimen was minimal, with only 27% grade 3+ neutropenia. This may be due to the reduced dosing schedule in the elderly/less fit patients ( n =9 of 127) previously described ( Supplementary Table 4 ).

The primary objective of FOCUS3 was to assess the feasibility of undertaking a complex biomarker-driven trial in a national multicentre setting. Although the study did not meet either of its ambitious pre-specified co-primary process outcome measures, the trial has shown that complex prospective biomarker-driven RCTs are possible on a substantial scale across the United Kingdom. Extra resources are required in the reference pathology laboratories to undertake the biomarker analyses, but within investigator sites and the trials office there is no requirement for special dedicated staff.

Potentially eligible patients were necessarily approached for consent at precisely the time when they had recently learned of the life-threatening status of their disease; our qualitative research showed this was the dominating concern in their minds. That we achieved our target patient number from 24 centres in 1 year demonstrated that the strategy for explaining the trial was successful and that, even under difficult circumstances, complex trials can be attractive to patients. Our four-step consent procedure was developed in consultation with patients and carers and was praised by the research ethics committee. The responses to the questionnaire administered after patients had read their stage 2 PIS showed high levels of understanding of the trial. The subsequent steps in the consent process, with specific patient consent forms for each molecular cohort and for each treatment, avoided information overload and provided only that information that was specifically relevant to the particular patient.

The logistics of retrieval of the FFPE blocks from the diagnostic hospitals was a major concern. Prior written agreement, a modest (£15) fee for retrieval and detailed sample tracking by CTU personnel minimised delay. The critical lessons were the need for excellent communication between all parties in the chain: from CRN to pathologist to the central laboratories to the coordinating trials unit.

A delay in reporting analysis results back to the MRC CTU was observed in 22 cases and was distressing to some patients. The delays were due to insufficient tumour in the block ( n =4), unexpected technical difficulties ( n =6), initial testing inconclusive or failed ( n =12). This was mitigated by allowing patients ( n =2) to start cycle one of chemotherapy using the infusional 5-FU and folinic acid backbone, which was common to all treatment protocols and then adding in the relevant additional agents for cycle 2 once the biomarker results were available.

Overall, the most important laboratory issue was reproducibility of IHC results. Although 100% concordance was achieved in the calling of KRAS and BRAF mutations between the two laboratories, it proved very difficult to perform and report the topo-1 IHC staining intensity in a sufficiently comparable way. Owing to technical- and manpower-based organisational limitations, it was not possible to completely replicate the manual staining methodology adopted initially by the Leeds laboratory in the Cardiff laboratory where an automated staining platform was used. Even what were deemed inconsequential differences between staining protocols contributed to this lack of consistency. For future studies, contributing diagnostic centres will use the same antibodies, protocol and automated staining platform. Detailed guidance on scoring, blinded replication in contributing centres with face to face comparison of discrepantly scored sections have been implemented for IHC tests in FOCUS4. On trial quality assurance by double reading of slides will ensure comparability of evaluation.

This trial was structured so that we could address four distinct hypotheses, any or all of which might be the subject of a subsequent phase III trial. Our first hypothesis, arising from the observation in the earlier FOCUS trial that patients with low topo-1 expression appear to gain no benefit from the addition of irinotecan to LV5FU2 ( Seymour et al, 2007 ; Braun et al, 2008 ), was supported and remains an intriguing one. Only 30 patients were randomised to this comparison because of the lower than expected rate of low topo-1 expression, but the high RR (60%) in the LV5FU2 only treated patients suggests further work in this area might be rewarding.

The second hypothesis proposed that patients with high topo-1 expression, who alone in FOCUS gained benefit from either irinotecan or oxaliplatin in comparison to 5-FU ( Braun et al, 2008 ), may derive additional benefit from the triple chemotherapy regimen. With the protocol-specified dose reductions, the regimen was well tolerated. However, in contrast to the international literature ( Falcone et al, 2007 , 2013 ), although patients had a minimally higher RR, there was no hint of a PFS benefit.

The third hypothesis, tested in 92 patients with KRAS and BRAF wild-type tumours, was that the addition of cetuximab would increase efficacy. This recapitulated the Crystal study ( Van Cutsem et al, 2009 , 2011 ) and benefits in PFS and RR were observed.

Finally, our fourth hypothesis for patients with KRAS or BRAF mutations (72 patients) was based on the limited data that bevacizumab retains efficacy in these patients ( Ince et al, 2005 ). No benefits on either RR or PFS were observed.

The FOCUS4 trial programme ( Kaplan et al, 2013 ) has recently opened to recruitment building on many of the lessons learned in FOCUS3. Patient and clinician enthusiasm for biomarker-stratified trials and the rapid accrual observed in FOCUS3 have encouraged us to be optimistic in our predicted recruitment targets: 2400 registered patients with over 1500 randomised into multiple biomarker-directed comparisons in 4 years for FOCUS4. Staged PISs have been designed with information given at the time of registration limited to that which is necessary for consent for release of tumour blocks, plus a minimal outline of the protocol so as to avoid information overload. Detailed quality assurance work has been undertaken between the two biomarker reference laboratories, especially for the IHC tests (PTEN and mismatch repair proteins). In FOCUS4, the allocation by biomarker to specific comparisons occurs for patients with stable or responding disease after 4 months of first-line chemotherapy. Knowing that in FOCUS3 we completed biomarker analysis in 99% of patients within 20 w.d. of consent, the FOCUS4 logistics (registration of patients up to 12 weeks into their first-line chemotherapy) should facilitate accrual. Detailed engagement with pathologists in referring hospitals and a relatively small (£15) payment per case enabled rapid release of blocks for central analysis in FOCUS3 and the same pattern has been used in FOCUS4. Perhaps most important is the strength of the team working established through FOCUS3, including patient representatives, clinicians, biomarker experts (including histopathologists, immunohistochemists, geneticists and technicians), statisticians, research nurses, pharmacists, trial managers and data managers. To this, we have added research network managers to ensure improved patient transfers between district general hospitals and experimental cancer medicine centres, who are required in FOCUS4 for some patients randomised to the novel agent combinations being studied.

The FOCUS3 trial was a feasibility study designed to address the challenges of patient acceptability, technical logistics, and to test a novel design for examining the predictive role of biomarkers for first-line therapy of ACRC. We have shown that such studies are feasible and very well received by participants. The central trial design concepts have been taken forward into a major UK trial programme FOCUS4-molecular selection of therapy in CRC: a molecularly stratified RCT programme, which opened to accrual in January 2014 ( Kaplan et al, 2013 ).

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Acknowledgements

We are indebted to the 332 patients and their families who participated in FOCUS3.

The design of the Medical Research Council (MRC) FOCUS3 trial was conceived and developed by the National Cancer Research Institute (NCRI) advanced colorectal cancer group. The trial was funded by the MRC. Additional support was provided by Merck KGaA (free cetuximab), Pfizer and Roche (educational research grants for the MRC colorectal research portfolio). The topo-1 antibody was provided free from Leica. Laboratory work in Leeds was also supported by funding from Yorkshire Cancer Research and the Leeds Experimental Cancer Medicines Centre. All tumour samples from patients who consented for future CRC research are stored at the Wales Cancer Bank.

The MRC was the overall sponsor of the study. FOCUS3 was approved by the Medicines and Healthcare Regulatory Agency (MHRA) on 12 June 2009 and Research Ethics Committee for Wales on 26 May 2009. The trial was coordinated by the MRC Clinical Trials Unit (CTU) following the principles of GCP, conducted with a Trial Management Group (TMG), monitored by a Data Monitoring Committee (DMC) and overseen by an independent Trial Steering Committee. Data collection at UK sites was supported by staff funding from the National Cancer Research Networks. All statistical analyses were performed at the MRC CTU. The trial is registered as an International Standard Randomised Controlled trial, number ISRCTN83171665.

Trial Management Group : TS Maughan (chair), R Adams, RH Wilson, MT Seymour, B Jasani, R Butler, S Richman, P Quirke, AM Nelson, GT Williams, G Taylor, H Grabsch, I Frayling, J Sampson, E Hodgkinson, P Rogers, M Pope and MRC CTU staff.

MRC Clinical Trials Unit: AM Meade, R Kaplan, D Fisher, SL Kenny, JK Mitchell, LL Nichols, L Harper, K Letchemanan, M Parmar.

Data Monitoring Committee: AM Meade, R Kaplan, D Fisher, TS Maughan, MT Seymour.

Trial Steering Committee: C Parker (current chair), R Rudd, J Whelan.

Sponsor: Medical Research Council.

Clinical Investigators (Institution—(number of patients contributed)): Bridgewater J, King J, Aggarwal A, Harinarayanan S, Melcher L, Karp Stephen (North Middlesex Hospital (32)), Furniss D, Wadsley J, Walkington L, Simmons T, Hornbuckle J, Pledge S, Clenton S (Weston Park Hospital (30)), Roy R, Dhadda A (Castle Hill Hospital (26)), Adams R, Maughan T, Jones R, Brewster A, Iqbal N, Arif, Crosby T (Velindre Hospital (23)), Falk S, Garadi K, Hopkins K (Bristol Haematology and Oncology Centre (18)), Seymour M, Swinson D, Anthoney A, (St James’ University Hospital, Leeds (18)), Leonard P, Mohamed M, (Whittington Hospital (14)), Benstead K, Farrugia D, Shepherd S (Cheltenham General Hospital (11)), Blesing C, Hyde K, Grant W (Great Western Hospital (10)), Lowdell C, Cleator S, Riddle P, Kenny L, Ahmad R (Charing Cross Hospital (9)), Hill M, Bhattacharjee P, Sevitt T, Summers J, Shah R (Maidstone Hospital (9)), Whillis D, Nicholls A, Ireland H, Macgregor C (Raigmore Hospital (8)), Sizer B, Basu D (Essex County Hospital (7)), Dent J, Hofmann U (Huddersfield Royal Infirmary (6)), Roy R, Butt M, Iqbal M (Diana, Princess of Wales Hospital (6)), Dent J (Calderdale Royal Hospital (6)), Hickish T, Osborne R (Poole Hospital (3)), Hickish T, Astras G, Purandare L (Royal Bournemouth Hospital (2)), Tahir S, Srinivasan G (Broomfield Hospital (2)), Gollins S, Kodavatiganti R (Wrexham Maelor Hospital (2)), Bale C, Mullard A, Fuller C, Williams R, Stuart N (Ysbyty Gwynedd (1)), Gollins S, Neupane R (Glan Clwyd Hospital (1)), Bessell E, Potter V (Nottingham University Hospital (0)), Tsang D (Southend University Hospital (0)).

In addition to the above-named individuals, we acknowledge the contributions of a large number of clinicians, research nurses, data managers and other clinical and support staff at the participating centres.

Author information

M J Pope and J K Pope: Malcolm and Janet Pope are Consumer Representatives; they also represent Velindre Hospital, Patient Liaison Group, Cardiff CF14 2TL, UK

Authors and Affiliations

CRUK/MRC Oxford Institute for Radiation Oncology, University of Oxford, Oxford OX3 7DQ, UK

T S Maughan

MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, London, WC2B 6NH, UK

A M Meade, D Fisher, L L Nichols, S L Kenny, M J Pope, J K Pope, M Parmar & R Kaplan

Cardiff University and Velindre Cancer Centre, Cardiff, UK

Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, LS9 7TF, UK

S D Richman, G R Taylor & P Quirke

University Hospital of Wales, Cardiff, CF14 4XW, UK

Centre for Cancer Research and Cell Biology, Queen’s University Belfast, Belfast, BT9 7AE, UK

Institute of Cancer and Genetics, Cardiff University, Cardiff, CF14 4XN, UK

B Jasani, G T Williams & J R Sampson

St James’s Institute of Oncology, University of Leeds, Leeds, LS9 7TF, UK

M T Seymour

Wales Cancer Trials Unit, Cardiff University, Cardiff, CF14 4YS, UK

A Nelson & C M Sampson

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, S5 7AU, UK

E Hodgkinson & D L Furniss

UCL Cancer Institute, London, WC1E 6BT, UK

J A Bridgewater

Department of Oncology, Castle Hill Hospital, East Riding of Yorkshire, HU16 5JQ, UK

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Correspondence to A M Meade .

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Maughan, T., Meade, A., Adams, R. et al. A feasibility study testing four hypotheses with phase II outcomes in advanced colorectal cancer (MRC FOCUS3): a model for randomised controlled trials in the era of personalised medicine?. Br J Cancer 110 , 2178–2186 (2014). https://doi.org/10.1038/bjc.2014.182

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Accepted : 13 March 2014

Published : 17 April 2014

Issue Date : 29 April 2014

DOI : https://doi.org/10.1038/bjc.2014.182

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Guidance for conducting feasibility and pilot studies for implementation trials

• Nicole Pearson   ORCID: orcid.org/0000-0003-2677-2327 1 , 2 ,
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Implementation trials aim to test the effects of implementation strategies on the adoption, integration or uptake of an evidence-based intervention within organisations or settings. Feasibility and pilot studies can assist with building and testing effective implementation strategies by helping to address uncertainties around design and methods, assessing potential implementation strategy effects and identifying potential causal mechanisms. This paper aims to provide broad guidance for the conduct of feasibility and pilot studies for implementation trials.

We convened a group with a mutual interest in the use of feasibility and pilot trials in implementation science including implementation and behavioural science experts and public health researchers. We conducted a literature review to identify existing recommendations for feasibility and pilot studies, as well as publications describing formative processes for implementation trials. In the absence of previous explicit guidance for the conduct of feasibility or pilot implementation trials specifically, we used the effectiveness-implementation hybrid trial design typology proposed by Curran and colleagues as a framework for conceptualising the application of feasibility and pilot testing of implementation interventions. We discuss and offer guidance regarding the aims, methods, design, measures, progression criteria and reporting for implementation feasibility and pilot studies.

Conclusions

This paper provides a resource for those undertaking preliminary work to enrich and inform larger scale implementation trials.

Peer Review reports

The failure to translate effective interventions for improving population and patient outcomes into policy and routine health service practice denies the community the benefits of investment in such research [ 1 ]. Improving the implementation of effective interventions has therefore been identified as a priority of health systems and research agencies internationally [ 2 , 3 , 4 , 5 , 6 ]. The increased emphasis on research translation has resulted in the rapid emergence of implementation science as a scientific discipline, with the goal of integrating effective medical and public health interventions into health care systems, policies and practice [ 1 ]. Implementation research aims to do this via the generation of new knowledge, including the evaluation of the effectiveness of implementation strategies [ 7 ]. The term “implementation strategies” is used to describe the methods or techniques (e.g. training, performance feedback, communities of practice) used to enhance the adoption, implementation and/or sustainability of evidence-based interventions (Fig. 1 ) [ 8 , 9 ].

Conceptual role of implementation strategies in improving intervention implementation and patient and public health outcomes

While there has been a rapid increase in the number of implementation trials over the past decade, the quality of trials has been criticised, and the effects of the strategies for such trials on implementation, patient or public health outcomes have been modest [ 11 , 12 , 13 ]. To improve the likelihood of impact, factors that may impede intervention implementation should be considered during intervention development and across each phase of the research translation process [ 2 ]. Feasibility and pilot studies play an important role in improving the conduct and quality of a definitive randomised controlled trial (RCT) for both intervention and implementation trials [ 10 ]. For clinical or public health interventions, pilot and feasibility studies may serve to identify potential refinements to the intervention, address uncertainties around the feasibility of intervention trial methods, or test preliminary effects of the intervention [ 10 ]. In implementation research, feasibility and pilot studies perform the same functions as those for intervention trials, however with a focus on developing or refining implementation strategies, refining research methods for an implementation intervention trial, or undertake preliminary testing of implementation strategies [ 14 , 15 ]. Despite this, reviews of implementation studies appear to suggest that few full implementation randomised controlled trials have undertaken feasibility and pilot work in advance of a larger trial [ 16 ].

A range of publications provides guidance for the conduct of feasibility and pilot studies for conventional clinical or public health efficacy trials including Guidance for Exploratory Studies of complex public health interventions [ 17 ] and the Consolidated Standards of Reporting Trials (CONSORT 2010) for Pilot and Feasibility trials [ 18 ]. However, given the differences between implementation trials and conventional clinical or public health efficacy trials, the field of implementation science has identified the need for nuanced guidance [ 14 , 15 , 16 , 19 , 20 ]. Specifically, unlike traditional feasibility and pilot studies that may include the preliminary testing of interventions on individual clinical or public health outcomes, implementation feasibility and pilot studies that explore strategies to improve intervention implementation often require assessing changes across multiple levels including individuals (e.g. service providers or clinicians) and organisational systems [ 21 ]. Due to the complexity of influencing behaviour change, the role of feasibility and pilot studies of implementation may also extend to identifying potential causal mechanisms of change and facilitate an iterative process of refining intervention strategies and optimising their impact [ 16 , 17 ]. In addition, where conventional clinical or public health efficacy trials are typically conducted under controlled conditions and directed mostly by researchers, implementation trials are more pragmatic [ 15 ]. As is the case for well conducted effectiveness trials, implementation trials often require partnerships with end-users and at times, the prioritisation of end-user needs over methods (e.g. random assignment) that seek to maximise internal validity [ 15 , 22 ]. These factors pose additional challenges for implementation researchers and underscore the need for guidance on conducting feasibility and pilot implementation studies.

Given the importance of feasibility and pilot studies in improving implementation strategies and the quality of full-scale trials of those implementation strategies, our aim is to provide practice guidance for those undertaking formative feasibility or pilot studies in the field of implementation science. Specifically, we seek to provide guidance pertaining to the three possible purposes of undertaking pilot and feasibility studies, namely (i) to inform implementation strategy development, (ii) to assess potential implementation strategy effects and (iii) to assess the feasibility of study methods.

A series of three facilitated group discussions were conducted with a group comprising of the 6 members from Canada, the U.S. and Australia (authors of the manuscript) that were mutually interested in the use of feasibility and pilot trials in implementation science. Members included international experts in implementation and behavioural science, public health and trial methods, and had considerable experience in conducting feasibility, pilot and/ or implementation trials. The group was responsible for developing the guidance document, including identification and synthesis of pertinent literature, and approving the final guidance.

To inform guidance development, a literature review was undertaken in electronic bibliographic databases and google, to identify and compile existing recommendations and guidelines for feasibility and pilot studies broadly. Through this process, we identified 30 such guidelines and recommendations relevant to our aim [ 2 , 10 , 14 , 15 , 17 , 18 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 ]. In addition, seminal methods and implementation science texts recommended by the group were examined. These included the CONSORT 2010 Statement: extension to randomised pilot and feasibility trials [ 18 ], the Medical Research Council’s framework for development and evaluation of randomised controlled trials for complex interventions to improve health [ 2 ], the National Institute of Health Research (NIHR) definitions [ 39 ] and the Quality Enhancement Research Initiative (QUERI) Implementation Guide [ 4 ]. A summary of feasibility and pilot study guidelines and recommendations, and that of seminal methods and implementation science texts, was compiled by two authors. This document served as the primary discussion document in meetings of the group. Additional targeted searches of the literature were undertaken in circumstances where the identified literature did not provide sufficient guidance. The manuscript was developed iteratively over 9 months via electronic circulation and comment by the group. Any differences in views between reviewers was discussed and resolved via consensus during scheduled international video-conference calls. All members of the group supported and approved the content of the final document.

The broad guidance provided is intended to be used as supplementary resources to existing seminal feasibility and pilot study resources. We used the definitions of feasibility and pilot studies as proposed by Eldridge and colleagues [ 10 ]. These definitions propose that any type of study relating to the preparation for a main study may be classified as a “feasibility study”, and that the term “pilot” study represents a subset of feasibility studies that specifically look at a design feature proposed for the main trial, whether in part of in full, that is being conducted on a smaller scale [ 10 ]. In addition, when referring to pilot studies, unless explicitly stated otherwise, we will primarily focus on pilot trials using a randomised design. We focus on randomised trials as such designs are the most common trial design in implementation research, and randomised designs may provide the most robust estimates of the potential effect of implementation strategies [ 46 ]. Those undertaking pilot studies that employ non-randomised designs need to interpret the guidance provided in this context. We acknowledge, however, that using randomised designs can prove particularly challenging in the field of implementation science, where research is often undertaken in real-world contexts with pragmatic constraints.

We used the effectiveness-implementation hybrid trial design typology proposed by Curran and colleagues as the framework for conceptualising the application of feasibility testing of implementation interventions [ 47 ]. The typology makes an explicit distinction between the purpose and methods of implementation and conventional clinical (or public health efficacy) trials. Specifically, the first two of the three hybrid designs may be relevant for implementation feasibility or pilot studies. Hybrid Type 1 trials are those designed to test the effectiveness of an intervention on clinical or public health outcomes (primary aim) while conducting a feasibility or pilot study for future implementation via observing and gathering information regarding implementation in a real-world setting/situation (secondary aim) [ 47 ]. Hybrid Type 2 trials involve the simultaneous testing of both the clinical intervention and the testing or feasibility of a formed implementation intervention/strategy as co-primary aims. For this design, “testing” is inclusive of pilot studies with an outcome measure and related hypothesis [ 47 ]. Hybrid Type 3 trials are definitive implementation trials designed to test the effectiveness of an implementation strategy whilst also collecting secondary outcome data on clinical or public health outcomes on a population of interest [ 47 ]. As the implementation aim of the trial is a definitively powered trial, it was not considered relevant to the conduct of feasibility and pilot studies in the field and will not be discussed.

Embedding of feasibility and pilot studies within Type 1 and Type 2 effectiveness-implementation hybrid trials has been recommended as an efficient way to increase the availability of information and evidence to accelerate the field of implementation science and the development and testing of implementation strategies [ 4 ]. However, implementation feasibility and pilot studies are also undertaken as stand-alone exploratory studies and do not include effectiveness measures in terms of the patient or public health outcomes. As such, in addition to discussing feasibility and pilot trials embedded in hybrid trial designs, we will also refer to stand-alone implementation feasibility and pilot studies.

An overview of guidance (aims, design, measures, sample size and power, progression criteria and reporting) for feasibility and pilot implementation studies can be found in Table 1 .

Purpose (aims)

The primary objective of hybrid type 1 trial is to assess the effectiveness of a clinical or public health intervention (rather than an implementation strategy) on the patient or population health outcomes [ 47 ]. Implementation strategies employed in these trials are often designed to maximise the likelihood of an intervention effect [ 51 ], and may not be intended to represent the strategy that would (or could feasibly), be used to support implementation in more “real world” contexts. Specific aims of implementation feasibility or pilot studies undertaken as part of Hybrid Type 1 trials are therefore formative and descriptive as the implementation strategy has not been fully formed nor will be tested. Thus, the purpose of a Hybrid Type 1 feasibility study is generally to inform the development or refinement of the implementation strategy rather than to test potential effects or mechanisms [ 22 , 47 ]. An example of a Hybrid Type 1 trial by Cabassa and colleagues is provided in Additional file 1 [ 52 ].

In Hybrid Type 2 trial designs, there is a dual purpose to test: (i) the clinical or public health effectiveness of the intervention on clinical or public health outcomes (e.g. measure of disease or health behaviour) and (ii) test or measure the impact of the implementation strategy on implementation outcomes (e.g. adoption of health policy in a community setting) [ 53 ]. However, testing the implementation strategy on implementation outcomes may be a secondary aim in these trials and positioned as a pilot [ 22 ]. In Hybrid Type 2 trial designs, the implementation strategy is more developed than in Hybrid Type 1 trials, resembling that intended for future testing in a definitive implementation randomised controlled trial. The dual testing of the evidence-based intervention and implementation interventions or strategies in Hybrid Type 2 trial designs allows for direct assessment of potential effects of an implementation strategy and exploration of components of the strategy to further refine logic models. Additionally, such trials allow for assessments of the feasibility, utility, acceptability or quality of research methods for use in a planned definitive trial. An example of a Hybrid Type 2 trial design by Barnes and colleagues [ 54 ] is included in Additional file 2 .

Non-hybrid pilot implementation studies are undertaken in the absence of a broader effectiveness trial. Such studies typically occur when the effectiveness of a clinical or public health intervention is well established, but robust strategies to promote its broader uptake and integration into clinical or public health services remain untested [ 15 ]. In these situations, implementation pilot studies may test or explore specific trial methods for a future definitive randomised implementation trial. Similarly, a pilot implementation study may also be undertaken in a way that provides a more rigorous formative evaluation of hypothesised implementation strategy mechanisms [ 55 ], or potential impact of implementation strategies [ 56 ], using similar approaches to that employed in Hybrid Type 2 trials. Examples of potential aims for feasibility and pilot studies are outlined in Table 2 .

For implementation feasibility or pilot studies, as is the case for these types of studies in general, the selection of research design should be guided by the specific research question that the study is seeking to address [ 57 ]. Although almost any study design may be used, researchers should review the merits and potential threats to internal and external validity to help guide the selection of research design for feasibility/pilot testing [ 15 ].

As Hybrid Type 1 trials are primarily concerned with testing the effectiveness of an intervention (rather than implementation strategy), the research design will typically employ power calculations and randomisation procedures at the health outcome level to measure the effect on behaviour, symptoms, functional and/or other clinical or public health outcomes. Hybrid Type 1 feasibility studies may employ a variety of designs usually nested within the experimental group (those receiving the intervention and any form of an implementation support strategy) of the broader efficacy trial [ 47 ]. Consistent with the aims of Hybrid Type 1 feasibility and pilot studies, the research designs employed are likely to be non-comparative. Cross-sectional surveys, interviews or document review, qualitative research or mix methods approaches may be used to assess implementation contextual factors, such as barriers and enablers to implementation and/or the acceptability, perceived feasibility or utility of implementation strategies or research methods [ 47 ].

Pilot implementation studies as part of Hybrid Type 2 designs can make use of the comparative design of the broader effectiveness trial to examine the potential effects of the implementation strategy [ 47 ] and more robustly assess the implementation mechanisms, determinants and influence of broader contextual factors [ 53 ]. In this trial type, mixed method and qualitative methods may complement the findings of between group (implementation strategy arm versus comparison) quantitative comparisons, enable triangulation and provide more comprehensive evidence to inform implementation strategy development and assessment. Stand-alone implementation feasibility and pilot implementation studies are free from the constraints and opportunities of research embedded in broader effectiveness trials. As such, research can be designed in a way that best addresses the explicit implementation objectives of the study. Specifically, non-hybrid pilot studies can maximise the applicability of study findings for future definitive trials by employing methods to directly test trial methods such as recruitment or retention strategies [ 17 ], enabling estimates of implementation strategies effects [ 56 ] or capturing data to explicitly test logic models or strategy mechanisms.

The selection of outcome measures should be linked directly to the objectives of the feasibility or pilot study. Where appropriate, measures should be objective or have suitable psychometric properties, such as evidence of reliability and validity [ 58 , 59 ]. Public health evaluation frameworks often guide the choice of outcome measure in feasibility and pilot implementation work and include RE_AIM [ 60 ], PRECEDE_PROCEED [ 61 ], Proctor and colleagues framework on outcomes for implementation research [ 62 ] and more recently, the “Implementation Mapping” framework [ 63 ]. Recent work by McKay and colleagues suggests a minimum data set of implementation outcomes that includes measures of adoption, reach, dose, fidelity and sustainability [ 46 ]. We discuss selected measures below and provide a summary in Table 3 [ 46 ]. Such measures could be assessed using quantitative or qualitative or mixed methods [ 46 ].

Measures to assess potential implementation strategy effects

In addition to assessing the effects of an intervention on individual clinical or public health outcomes, Hybrid Type 2 trials (and some non-hybrid pilot studies) are interested in measures of the potential effects of an implementation strategy on desired organisational or clinician practice change such as adherence to a guideline, process, clinical standard or delivery of a program [ 62 ]. A range of potential outcomes that could be used to assess implementation strategy effects has been identified, including measures of adoption, reach, fidelity and sustainability [ 46 ]. These outcomes are described in Table 2 , including definitions and examples of how they may be applied to the implementation component of innovation being piloted. Standardised tools to assess these outcomes are often unavailable due to the unique nature of interventions being implemented and the variable (and changing) implementation context in which the research is undertaken [ 64 ]. Researchers may collect outcome data for these measures as part of environmental observations, self-completed checklists or administrative records, audio recording of client sessions or other methods suited to their study and context [ 62 ]. The limitations of such methods, however, need to be considered.

Measures to inform the design or development of the implementation strategy

Measures informing the design or development of the implementation strategy are potentially part of all types of feasibility and pilot implementation studies. An understanding of the determinants of implementation is critical to implementation strategy development. A range of theoretical determinant frameworks have been published which describe factors that may influence intervention implementation [ 65 ], and systematic reviews have been undertaken describing the psychometric properties of many of these measures [ 64 , 66 ]. McKay and colleagues have also identified a priority set of determinants for implementation trials that could be considered for use in implementation feasibility and pilot studies, including measures of context, acceptability, adaptability, feasibility, compatibility, cost, culture, dose, complexity and self-efficacy [ 46 ]. These determinants are described in Table 3 , including definitions and how such measures may be applied to an implementation feasibility or pilot study. Researchers should consider, however, the application of such measures to assess both the intervention that is being implemented (as in a conventional intervention feasibility and pilot study) and the strategy that is being employed to facilitate its implementation, given the importance of the interaction between these factors and implementation success [ 46 ]. Examples of the potential application of measures to both the intervention and its implementation strategies have been outlined elsewhere [ 46 ]. Although a range of quantitative tools could be used to measure such determinants [ 58 , 66 ], qualitative or mixed methods are generally recommended given the capacity of qualitative measures to provide depth to the interpretation of such evaluations [ 40 ].

Measures of potential implementation determinants may be included to build or enhance logic models (Hybrid Type 1 and 2 feasibility and pilot studies) and explore implementation strategy mechanisms (Hybrid Type 2 pilot studies and non-hybrid pilot studies) [ 67 ]. If exploring strategy mechanisms, a hypothesized logic model underpinning the implementation strategy should be articulated including strategy-mechanism linkages, which are required to guide the measurement of key determinants [ 55 , 63 ]. An important determinant which can complicate logic model specification and measurement is the process of adaptation—modifications to the intervention or its delivery (implementation), through the input of service providers or implementers [ 68 ]. Logic models should specify components of implementation strategies thought to be “core” to their effects and those which are thought to be “non-core” where adaptation may occur without adversely impacting on effects. Stirman and colleagues propose a method for assessing adaptations that could be considered for use in pilot and feasibility studies of implementation trials [ 69 ]. Figure 2 provides an example of some of the implementation logic model components that may be developed or refined as part of feasibility or pilot studies of implementation [ 15 , 63 ].

Example of components of an Implementation logic model

Measures to assess the feasibility of study methods

Measures of implementation feasibility and pilot study methods are similar to those of conventional studies for clinical or public health interventions. For example, standard measures of study participation and thresholds for study attrition (e.g. >20%) rates [ 73 ] can be employed in implementation studies [ 67 ]. Previous studies have also surveyed study data collectors to assess the success of blinding strategies [ 74 ]. Researchers may also consider assessing participation or adherence to implementation data collection procedures, the comprehension of survey items, data management strategies or other measures of feasibility of study methods [ 15 ].

Pilot study sample size and power

In effectiveness trials, power calculations and sample size decisions are primarily based on the detection of a clinically meaningful difference in measures of the effects of the intervention on the patient or public health outcomes such as behaviour, disease, symptomatology or functional outcomes [ 24 ]. In this context, the available study sample for implementation measures included in Hybrid Type 1 or 2 feasibility and pilot studies may be constrained by the sample and power calculations of the broader effectiveness trial in which they are embedded [ 47 ]. Nonetheless, a justification for the anticipated sample size for all implementation feasibility or pilot studies (hybrid or stand-alone) is recommended [ 18 ], to ensure that implementation measures and outcomes achieve sufficient estimates of precision to be useful. For Hybrid type 2 and relevant stand-alone implementation pilot studies, sample size calculations for implementation outcomes should seek to achieve adequate estimates of precision deemed sufficient to inform progression to a fully powered trial [ 18 ].

Progression criteria

Stating progression criteria when reporting feasibility and pilot studies is recommended as part of the CONSORT 2010 extension to randomised pilot and feasibility trials guidelines [ 18 ]. Generally, it is recommended that progression criteria should be set a priori and be specific to the feasibility measures, components and/or outcomes assessed in the study [ 18 ]. While little guidance is available, ideas around suitable progression criteria include assessment of uncertainties around feasibility, meeting recruitment targets, cost-effectiveness and refining causal hypotheses to be tested in future trials [ 17 ]. When developing progression criteria, the use of guidelines is suggested rather than strict thresholds [ 18 ], in order to allow for appropriate interpretation and exploration of potential solutions, for example, the use of a traffic light system with varying levels of acceptability [ 17 , 24 ]. For example, Thabane and colleagues recommend that, in general, the outcome of a pilot study can be one of the following: (i) stop—main study not feasible (red); (ii) continue, but modify protocol—feasible with modifications (yellow); (iii) continue without modifications, but monitor closely—feasible with close monitoring and (iv) continue without modifications (green) (44)p5.

As the goal of Hybrid Type 1 implementation component is usually formative, it may not be necessary to set additional progression criteria in terms of the implementation outcomes and measures examined. As Hybrid Type 2 trials test an intervention and can pilot an implementation strategy, criteria for these and non-hybrid pilot studies may set progression criteria based on evidence of potential effects but may also consider the feasibility of trial methods, service provider, organisational or patient (or community) acceptability, fit with organisational systems and cost-effectiveness [ 17 ]. In many instances, the progression of implementation pilot studies will often require the input and agreement of stakeholders [ 27 ]. As such, the establishment of progression criteria and the interpretation of pilot and feasibility study findings in the context of such criteria require stakeholder input [ 27 ].

Reporting suggestions

As formal reporting guidelines do not exist for hybrid trial designs, we would recommend that feasibility and pilot studies as part of hybrid designs draw upon best practice recommendations from relevant reporting standards such as the CONSORT extension for randomised pilot and feasibility trials, the Standards for Reporting Implementation Studies (STaRI) guidelines and the Template for Intervention Description and Replication (TIDieR) guide as well as any other design relevant reporting standards [ 48 , 50 , 75 ]. These, and further reporting guidelines, specific to the particular research design chosen, can be accessed as part of the EQUATOR (Enhancing the QUAility and Transparency Of health Research) network—a repository for reporting guidance [ 76 ]. In addition, researchers should specify the type of implementation feasibility or pilot study being undertaken using accepted definitions. If applicable, specification and justification behind the choice of hybrid trial design should also be stated. In line with existing recommendations for reporting of implementation trials generally, reporting on the referent of outcomes (e.g. specifying if the measure in relation to the specific intervention or the implementation strategy) [ 62 ], is also particularly pertinent when reporting hybrid trial designs.

Concerns are often raised regarding the quality of implementation trials and their capacity to contribute to the collective evidence base [ 3 ]. Although there have been many recent developments in the standardisation of guidance for implementation trials, information on the conduct of feasibility and pilot studies for implementation interventions remains limited, potentially contributing to a lack of exploratory work in this area and a limited evidence base to inform effective implementation intervention design and conduct [ 15 ]. To address this, we synthesised the existing literature and provide commentary and guidance for the conduct of implementation feasibility and pilot studies. To our knowledge, this work is the first to do so and is an important first step to the development of standardised guidelines for implementation-related feasibility and pilot studies.

Availability of data and materials

Not applicable.

Abbreviations

Randomised controlled trial

Consolidated Standards of Reporting Trials

Enhancing the QUAility and Transparency Of health Research

Standards for Reporting Implementation Studies

Strengthening the Reporting of Observational Studies in Epidemiology

Template for Intervention Description and Replication

National Institute of Health Research

Quality Enhancement Research Initiative

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Acknowledgements

Associate Professor Luke Wolfenden receives salary support from a NHMRC Career Development Fellowship (grant ID: APP1128348) and Heart Foundation Future Leader Fellowship (grant ID: 101175). Dr Sze Lin Yoong is a postdoctoral research fellow funded by the National Heart Foundation. A/Prof Maureen C. Ashe is supported by the Canada Research Chairs program.

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Pearson, N., Naylor, PJ., Ashe, M.C. et al. Guidance for conducting feasibility and pilot studies for implementation trials. Pilot Feasibility Stud 6 , 167 (2020). https://doi.org/10.1186/s40814-020-00634-w

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Feasibility Studies: What They Are, How They Are Done, and What We Can Learn From Them

Anne M. Kolenic

Nursing clinical research is a growing field, and as more nurses become engaged in conducting clinical research, feasibility studies may be their first encounter. Understanding what they are, how to conduct them, and the importance of properly reporting their outcomes is vital to the continued advancement of nursing science.

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What Is a Feasibility Study? 6 Types and Practical Tips

A feasibility study is an analysis to determine the practicality of a proposed project or business venture—but there’s more than just one type.

Here’s a business idea: Everyone prefers to keep a perfect body temperature no matter the weather, so why not create clothing that maintains comfort in both hot and cold temperatures? The problem is it would require built-in heating and cooling mechanisms, adding weight, bulk, and electricity needs. In other words, it’s an intriguing idea, but it’s not feasible.

Decision makers and project managers must constantly assess if great ideas are truly feasible in the real world. To do this, they might conduct a feasibility study to determine if there’s a practical way to bring these ideas to life. Feasibility studies consider things like cost, resource availability, technical capacity, and potential risks.

Here’s an overview of feasibility studies, with tips on how to conduct your own feasibility analysis.

What is a feasibility study?

A feasibility study is a preliminary analysis to determine the viability and practicality of a proposed project or new business venture. It can be commissioned by a government, a business organization, or an individual during an analysis phase. Feasibility studies help stakeholders understand potential risks, benefits, costs, and challenges to predict whether a project should be pursued, modified, or simply abandoned.

A typical feasibility study evaluates timelines, budgeting, market research , supply chain information, technological considerations, and legal requirements. Assessing these feasibility factors in the early stages helps determine if the proposed project is a worthwhile investment of your time, money, and resources.

A study usually culminates in a feasibility report you can present to business owners and project leaders. The report centralizes your findings and makes a declaration about the new project or business’s viability.

Benefits of feasibility studies

Informed decision-making, financial viability assessment, risk assessment, resource management, stakeholder confidence.

Conducting a feasibility study helps determine how likely your idea or venture is to succeed. Here are the five main benefits of a feasibility assessment:

A successful business or project feasibility study helps you make informed decisions based on data and analysis rather than assumptions or guesswork. Your proposed business venture should rely on concrete numbers, not gut instinct or anecdotal evidence.

Does a market survey show there’s a viable customer base? Do your financial projections suggest the project can become profitable? Does your project management team think you have the technical resources to execute your plan? A proper feasibility study report answers these questions with solid data.

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Many great business ideas are derailed by a project’s cost. A feasibility study helps you understand if you have the financial resources to see your project through. This can prevent costly investments in projects unlikely to yield expected returns and protect your organization’s financial health.

A feasibility study can warn your management team of potential risks in a business plan. It can identify potential challenges related to money, market size, technical abilities, and legal risks. Addressing these challenges early can spare you from severe consequences, saving time, money, and resources.

Implementing a proposed plan typically requires time, physical resources, human effort, and capital. A full-scale feasibility study takes a holistic look at the resources needed to realize a particular project and determines if your organization has or can allocate and manage these resources effectively.

A well-conducted feasibility study shows stakeholders—like investors, partners, managers, and employees—that you’ve thoroughly evaluated your project before diving in. You can show them your project plan, the risks involved, the resources required, and your predicted likelihood of success. Showing your partners what lies under the hood of your project can inspire emotional and capital investment.

6 types of feasibility studies

• Operational
• Environmental

Different initiatives succeed or fail because of various factors, so feasibility studies address distinct topics. Here are six of the most commonly commissioned feasibility studies:

A market feasibility study assesses the demand for a product or service within a target market. It analyzes the total addressable market (TAM) , target customers, competition , market trends, and potential market share. Note that this type of market analysis doesn’t involve creating a marketing strategy; it determines whether there’s even a viable market to begin with.

2. Technical

A technical feasibility study examines the technical resources needed to complete a project, including the required technology, equipment, and expertise. It then assesses whether the organization has achieved the technical development required to achieve tactical or business success.

A legal feasibility study aims to identify the legal factors affecting your project, ensuring it complies with relevant laws and regulations, including zoning laws, licensing, permits, and intellectual property .

4. Financial

A financial feasibility study—or economic feasibility study—analyzes a project’s costs, revenues, and profitability to assess its economic viability and funding. This type of study often includes a business plan , projected income statement , and overall financial analysis. Some lending institutions require this study for loan approval.

5. Operational

An operational feasibility study aims to assess whether you have the operational capacity to implement the proposed project considering your physical assets, human resources, organizational structure , company culture, and workflows.

6. Environmental

An environmental feasibility study assesses a project’s potential environmental impact and outlines measures to mitigate negative effects. It also ensures alignment with environmental regulations and your organization’s sustainability goals.

How to conduct a feasibility study

• Define the project and its scope
• Conduct preliminary analysis
• Evaluate market feasibility
• Assess technical and operational feasibility
• Analyze financial feasibility
• Review legal and environmental considerations
• Prepare the final report

Using this feasibility study template to guide your process, here’s how to conduct a comprehensive feasibility study:

1. Define the project and its scope

Clearly outline your project's objectives, goals, and key deliverables. This includes identifying the problem or opportunity the project aims to address and setting specific criteria for success, including key performance indicators (KPIs) .

For example, Gloria Hwang conceived of her idea for a bike helmet company, Thousand , after her friend tragically died in a cycling accident. Her goal: Create a stylish helmet for commuters. As she explains on an episode of Shopify Masters , “If you can make a helmet people actually want to wear, you can help save lives.” Her company’s very name references her mission to save 1,000 bike riders’ lives—a key deliverable she reached in 2023.

2. Conduct preliminary analysis

A preliminary analysis provides a general assessment to determine if your project is worth pursuing. Roughly evaluate the potential market, technical requirements, financial costs, and legal constraints to identify any major obstacles. If the project clears this initial requirements analysis phase, you can dive deeper into all these topics.

When Gloria set out to research her business idea, she found that most bike helmet companies catered to high-tech riders or cycling enthusiasts—not casual riders.

“From my perspective, it was just [about] trying to find and make a product that was driven by consumer insights,” says Gloria.

Knowing that the product she wanted didn’t exist inspired her to dig deeper into research and development.

3. Evaluate market feasibility

Assuming your preliminary analysis suggests the project is viable, proceed with a comprehensive market assessment . Analyze the demand for your product or service. Profile target customers , estimate market size, size up the competition , and identify market trends.

Gloria, for example, sent out 50 surveys to people she knew with an interest in biking or skateboarding and asked what they would like to see in a helmet. In the responses, it became clear there was demand for the type of helmet she wanted to make. People expressed their primary concerns were about safety, convenience, and price—data Gloria used to refine her product’s value proposition .

4. Assess technical and operational feasibility

If a viable market exists, decide whether your organization is equipped to serve it. Examine the technical requirements of your project, including technology, resources, and expertise. Assess your organization’s capacity for implementation and operation, paying special attention to human resources, infrastructure, and company culture.

For example, Gloria knew she needed to design a helmet that had never existed before on a budget that wouldn’t allow her to hire an expensive product development firm.

“Thankfully [my dad] happened to be a former NASA engineer,” Gloria says.

5. Analyze financial feasibility

Take a hard look at whether you have the financial means to execute the project. Develop a detailed financial analysis, including cost estimates, revenue projections, and funding sources. What will the opening day balance sheet look like? When will the project be profitable? Consider creating financial models to assess the project’s profitability, return on investment (ROI) , and break-even point .

One tip: Gloria recommends finding mid-sized manufacturers to help you make your business a reality since the largest, most well-known companies may not prioritize your small business’s needs.

“Finding someone who's in it with you from a partnership perspective, I think is the best thing to do,” she says.

6. Review legal and environmental considerations

Your project will only succeed if it complies with applicable laws, regulations, and environmental standards. Determine what permits and licenses you need, and whether an environmental impact assessment is necessary.

For Gloria, this meant making sure her designs met the safety standards set for cycling and skateboarding helmets so her customers could wear her helmets for both use cases.

7. Prepare the final report

Compile your findings into a detailed report covering all aspects of the feasibility study. Start with an executive summary outlining potential business scenarios based on the information you’ve amassed. Present the report to stakeholders, highlighting key insights and recommendations. Your team can then make an informed decision about whether to proceed with the project, pursue business alternatives, or scrap the endeavor altogether.

For Gloria, the time she spent researching and refining her concept paid off. She’s reached her goal of saving lives with her helmets while getting people who never wore helmets before to start prioritizing their safety—without sacrificing style.

“It’s all centered around this idea of, ‘How can products help you express your personal style?’” Gloria says.

Because when your bike helmet expresses your style, you’re more likely to wear it.

Feasibility study FAQ

How do you write a feasibility study.

To write a feasibility study, define your project scope, conduct thorough analyses of market, technical, financial, legal, and operational factors, and compile the findings into a comprehensive report with recommendations for decision-making.

What should a feasibility study include?

A feasibility study should include an assessment of your project's market potential, technical requirements, financial viability, legal considerations, and operational capacity.

What is the average cost of a feasibility study?

The cost of a feasibility study varies tremendously based on the scope and nature of your project. Some business veterans estimate a study should be about 1% of your project’s total cost. For example, if you’re planning a $100,000 project, your feasibility study might cost around $1,000 to conduct.

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Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework

Sandra m. eldridge.

1 Centre for Primary Care and Public Health, Queen Mary University of London, London, United Kingdom

Gillian A. Lancaster

2 Department of Mathematics and Statistics, Lancaster University, Lancaster, Lancashire, United Kingdom

Michael J. Campbell

3 School of Health and Related Research, University of Sheffield, Sheffield, South Yorkshire, United Kingdom

Lehana Thabane

4 Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada

Sally Hopewell

5 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, Oxfordshire, United Kingdom

Claire L. Coleman

Christine m. bond.

6 Centre of Academic Primary Care, University of Aberdeen, Aberdeen, Scotland, United Kingdom

Conceived and designed the experiments: SE GL MC LT SH CB. Performed the experiments: SE GL MC LT SH CB CC. Analyzed the data: SE GL MC LT SH CB CC. Contributed reagents/materials/analysis tools: SE GL MC LT SH CB. Wrote the paper: SE GL MC LT SH CB CC.

Associated Data

Due to a requirement by the ethics committee that the authors specified when the data will be destroyed, the authors are not able to give unlimited access to the Delphi study quantitative data. These data are available from Professor Sandra Eldridge. Data will be available upon request to all interested researchers. Qualitative data from the Delphi study are not available because the authors do not have consent from participants for wider distribution of this more sensitive data.

We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms ‘pilot’ and ‘feasibility’ in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms ‘feasibility’ or ‘pilot’ as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term ‘feasibility’ in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

Introduction

There is a large and growing number of studies in the literature that authors describe as feasibility or pilot studies. In this paper we focus on feasibility and pilot studies conducted in preparation for a future definitive randomised controlled trial (RCT) that aims to assess the effect of an intervention. We are primarily concerned with stand-alone studies that are completed before the start of such a definitive RCT, and do not specifically cover internal pilot studies which are designed as the early stage of a definitive RCT; work on the conduct of internal pilot studies is currently being carried out by the UK MRC Network of Hubs for Trials Methodology Research. One motivating factor for the work reported in this paper was the inconsistent use of terms. For example, in the context of RCTs ‘pilot study’ is sometimes used to refer to a study addressing feasibility in preparation for a larger RCT, but at other times it is used to refer to a small scale, often opportunistic, RCT which assesses efficacy or effectiveness.

A second, related, motivating factor was the lack of agreement in the research community about the use of the terms ‘pilot’ and ‘feasibility’ in relation to studies conducted in preparation for a future definitive RCT. In a seminal paper in 2004 reviewing the literature in relation to pilot and feasibility studies conducted in preparation for an RCT [ 1 ], Lancaster et al reported that they could find no formal guidance as to what constituted a pilot study. In the updated UK Medical Research Council (MRC) guidance on designing and evaluating complex interventions published four years later, feasibility and pilot studies are explicitly recommended, particularly in relation to identifying problems that might occur in an ensuing RCT of a complex intervention [ 2 ]. However, while the guidance suggests possible aims of such studies, for example, testing procedures for their acceptability, estimating the likely rates of recruitment and retention of subjects, and the calculation of appropriate sample sizes, no explicit definitions of a ‘pilot study’ or ‘feasibility study’ are provided. In 2010, Thabane and colleagues presented a number of definitions of pilot studies taken from various health related websites [ 3 ]. While these definitions vary, most have in common the idea of conducting a study in advance of a larger, more comprehensive, investigation. Thabane et al also considered the relationship between pilot and feasibility, suggesting that feasibility should be the main emphasis of a pilot study and that ‘a pilot study is synonymous with a feasibility study intended to guide the planning of a large scale investigation’. However, at about the same time, the UK National Institute for Health Research (NIHR) developed definitions of pilot and feasibility studies that are mutually exclusive, suggesting that feasibility studies occurred slightly earlier in the research process and that pilot studies are ‘a version of the main study that is run in miniature to test whether the components of the main study can all work together’. Arain et al . felt that the NIHR definitions were helpful, and showed that studies identified using the keyword ‘feasibility’ had different characteristics from those identified as ‘pilot’ studies [ 4 ]. The NIHR wording for pilot studies has been changed more recently to ‘a smaller version of the main study used to test whether the components of the main study can all work together’ ( Fig 1 ). Nevertheless, it still contrasts with the MRC framework guidance that explicitly states: ‘A pilot study need not be a “scale model” of the planned main-stage evaluation, but should address the main uncertainties that have been identified in the development work’ [ 2 ]. These various, sometimes conflicting, approaches to the interpretation of the terms ‘pilot’ and ‘feasibility’ exemplify differences in current usage and opinion in the research community.

While lack of agreement about definitions may not necessarily affect research quality, it can become problematic when trying to develop guidance for research conduct because of the need for clarity over what the guidance applies to and therefore what it should contain. Previous research has identified weaknesses in the reporting and conduct of pilot and feasibility studies [ 1 , 3 , 4 , 7 ], particularly in relation to studies conducted in preparation for a future definitive RCT assessing the effect of an intervention or therapy. While undertaking research to develop guidance to address some of the weaknesses in reporting these studies, we became convinced by the current interest in this area, the lack of clarity, and the differences of opinion in the research community, that a re-evaluation of the definitions of pilot and feasibility studies was needed. This paper describes the process and results of this re-evaluation and suggests a conceptual framework within which researchers can operate when designing and reporting pilot/feasibility studies. Since our work on reporting guidelines focused specifically on pilot and feasibility studies in preparation for an RCT assessing the effect of some intervention or therapy, we restrict our re-evaluation to these types of pilot and feasibility studies.

The process of developing and validating the conceptual framework for defining pilot and feasibility studies was, to a large extent, integral to the development of our reporting guidelines, the core components of which were a large Delphi study and an international expert consensus meeting focused on developing an extension of the 2010 CONSORT statement for RCTs [ 8 ] to randomised pilot studies. The reporting guidelines, Delphi study and consensus meeting are therefore referred to in this paper. However, the reporting guidelines will be reported separately; this paper focuses on our conceptual framework.

Developing a conceptual framework—Delphi study

Following research team discussion of our previous experience with, and research on, pilot and feasibility studies we initially produced mutually exclusive definitions of pilot and feasibility studies based on, but not identical to, the definitions used by the NIHR. We drew up two draft reporting checklists based on the 2010 CONSORT statement [ 8 ], one for what we had defined as feasibility studies and one for what we had defined as pilot studies. We constructed a Delphi survey, administered on-line by Clinvivo [ 9 ], to obtain consensus on checklist items for inclusion in a reporting guideline, and views on the definitions. Following user-testing of a draft version of the survey with a purposive sample of researchers active in the field of trials and pilot studies, and a workshop at the 2013 Society for Clinical Trials Conference in Boston, we further refined the definitions, checklists, survey introduction and added additional questions.

The first round of the main Delphi survey included: a description and explanation of our definitions of pilot and feasibility studies including examples (Figs ​ (Figs2 2 and ​ and3); 3 ); questions about participants’ characteristics; 67 proposed items for the two checklists and questions about overall appropriateness of the guidelines for feasibility or pilot studies; and four questions related to the definitions of feasibility and pilot studies: How appropriate do you think our definition for a pilot study conducted in preparation for an RCT is ? How appropriate do you think our definition for a feasibility study conducted in preparation for an RCT is ? How appropriate is the way we have distinguished between two different types of study conducted in preparation for an RCT ? How appropriate are the labels ‘pilot’ and ‘feasibility’ for the two types of study we have distinguished ? Participants were asked to rate their answers to the four questions on a nine-point scale from ‘not at all appropriate’ to ‘completely appropriate’. There was also a space for open comments about the definitions. The second round included results from the first round and again asked for further comments about the definitions.

Participants for the main survey were identified as likely users of the checklist including trialists, methodologists, statisticians, funders and journal editors. Three hundred and seventy potential participants were approached by email from the project team or directly from Clinvivo. These were individuals identified based on personal networks, authors of relevant studies in the literature, members of the Canadian Institute of Health Research, Biostatistics section of Statistics Society of Canada, and the American Statistical Society. The International Society for Clinical Biostatistics and the Society for Clinical Trials kindly forwarded our email to their entire membership. There was a link within the email to the on-line questionnaire. Each round lasted three weeks and participants were sent one reminder a week before the closure of each survey. The survey took place between August and October 2013. Ethical approval was granted by the ScHARR research ethics committee at the University of Sheffield.

Developing a conceptual framework—Open meeting and research team meetings

The results of the Delphi survey pertaining to the definitions of feasibility and pilot studies were presented to an open meeting at the 2 nd UK MRC Trials Methodology Conference in Edinburgh in November 2013 [ 13 ]. Attendees chose their preferred proposition from four propositions regarding the definitions, based variously on our original definitions, the NIHR and MRC views of pilot and feasibility studies and different views expressed in the Delphi survey. At a subsequent two-day research team meeting we collated the findings from the Delphi survey and the open meeting, and considered definitions of piloting and feasiblity outside the health research context found from on-line searches using the terms ‘pilot definition’, ‘feasiblity definition’, ‘pilot study definition’ and ‘feasibility study definition’ in Google. We expected all searches to give a very large number of hits and examined the first two pages of hits only from each search. From this, we developed a conceptual framework reflecting consensus about the definitions, types and roles of feasibility and pilot studies conducted in preparation for an RCT evaluating the effect of an intervention or therapy. To ensure we incorporated the views of all researchers likely to be conducting pilot/feasiblity studies, two qualitative researchers joined the second day of the meeting which focused on agreeing this framework. Throughout this process we continually referred back to examples that we had identified to check that our emerging definitions were workable.

Validating the conceptual framework—systematic review

To validate the proposed conceptual framework, we identified a selection of recently reported studies that fitted our definition of pilot and feasibility studies, and tested a number of hypotheses in relation to these studies. We expected that approximately 30 reports would be sufficient to test the hypotheses. We conducted a systematic review to identify studies that authors described as pilot or feasibility studies, by searching Medline via PubMed for studies that had the words ‘pilot’ or ‘feasibility’ in the title. To increase the likelihood that the studies would be those conducted in preparation for a randomised controlled trial of the effect of a therapy or intervention we limited our search to those that contained the word ‘trial’ in the title or abstract. For full details of the search strategy see S1 Fig .

To focus on current practice, we selected the 150 most recent studies from those identified by the electronic search. We did not exclude protocols since we were primarily interested in identifying the way researchers characterised their study and any possible future study and the relationship between them; we expected investigators to describe these aspects of their studies in a similar way in protocols and reports of findings. Two research team members independently reviewed study abstracts to assess whether each study fitted our working definition of a pilot or feasibility study in preparation for an RCT evaluating the effect of an intervention or therapy. Where reviewers disagreed, studies were classed as ‘possible inclusions’ and disagreements resolved by discussion with referral to the full text of the paper as necessary. Given the difficulty of interpreting some reports and to ensure that all research team members agreed on inclusion, the whole team then reviewed relevant extracted sections of the papers provisionally agreed for inclusion. We recognised that abstracts of some studies might not include appropriate information, and therefore that our initial abstract review could have excluded some relevant studies; we explored the extent of this potential omission of studies by reviewing the full texts of a random sample of 30 studies from the original 150. Since our prime goal was to identify a manageable number of relevant studies in order to test our hypotheses rather than identify all possible relevant studies we did not include any additional studies as a result of this exploratory study.

We postulated that the following hypotheses would support our conceptual framework:

• The words ‘pilot’ and ‘feasibility’ are both used in the literature to describe studies undertaken in preparation for an RCT evaluating the effect of an intervention or therapy
• It is possible to identify a subset of studies within the literature that are RCTs conducted in preparation for a larger RCT which evaluates the effect of an intervention or therapy. Authors do not use the term ‘pilot trial’ consistently in relation to these studies.
• Within the literature it is not possible to apply unique mutually exclusive definitions of pilot and feasibility studies in preparation for an RCT evaluating the effect of an intervention or therapy that are consistent with the way authors describe their studies.
• Amongst feasibility studies in preparation for an RCT which evaluates the effect of an intervention or therapy it is possible to identify some studies that are not pilot studies as defined within our conceptual framework, but are studies that acquire information about the feasibility of applying an intervention in a future study.

In order to explore these hypotheses, we categorised included studies into three groups that tallied with our framework (see results for details): randomised pilot studies, non-randomised pilot studies, feasibility studies that are not pilot studies. We also extracted data on objectives, and the phrases that indicated that the studies were conducted in preparation for a subsequent RCT.

Validating the conceptual framework—Consensus meeting

We also took an explanation and visual representation of our framework to an international consensus meeting primarily designed to reach consensus on an extension of the 2010 CONSORT statement to randomised pilot studies. There were 19 invited participants with known expertise, experience, or interest in pilot and feasibility studies, including representatives of CONSORT, funders, journal editors, and those who had been involved in writing the NIHR definitions of pilot and feasibility studies and the MRC guidance on designing and evaluating complex interventions. Thus this was an ideal forum in which to discuss the framework also. This project was not concerned with any specific disease, and was methodological in design; no patients or public were involved.

Ninety-three individuals, including chief investigators, statisticians, trial managers, clinicians, research assistants and a funder, participated in the first round of the Delphi survey and 79 in the second round. Over 70% of participants in the first round felt that our definitions, the way we had distinguished between pilot and feasibility studies, and the labels ‘pilot’ and ‘feasibility’ were appropriate. However, these four items had some of the lowest appropriateness ratings in the survey and there were a large number of comments both in direct response to our four survey items related to appropriateness of definitions, and in open comment boxes elsewhere in the survey. Some of these comments are presented in Fig 4 . Some participants commented favourably on the definitions we had drawn up (quote 1) but others were confused by them (quote 2). Several compared our definitions to the NIHR definitions pointing out the differences (quote 3) and suggesting this might make it particularly difficult for the research community to understand our definitions (quote 4). Some expressed their own views about the definitions (quote 5); largely these tallied with the NIHR definitions. Others noted that both the concept of feasibility and the word itself were often used in relation to studies which investigators referred to as pilot studies (quote 6). Others questioned whether it was practically and/or theoretically possible to make a distinction between pilot and feasibility studies (quote 6, quote 7), suggesting that the two terms are not mutually exclusive and that feasibility was more of an umbrella term for studies conducted prior to the main trial. Some participants felt that, using our definitions, feasibility studies would be less structured and more variable and therefore their quality would be less appropriately assessed via a checklist (quote 8). These responses regarding definitions mirrored what we had found in the user-testing of the Delphi survey, the Society for Clinical Trials workshop, and differences of opinion already apparent in the literature. In the second round of the survey there were few comments about definitions.

There was a wide range of participants in the open meeting, including senior quantitative and qualitative methodologists, and a funding body representative. The four propositions we devised to cover different views about definitions of pilot and feasibility studies are shown in Fig 5 . Fourteen out of the fifteen attendees who voted on these propositions preferred propositions 3 or 4, based on comments from the Delphi survey and the MRC guidance on designing and evaluating complex interventions respectively. Neither of these propositions implied mutually exclusive definitions of pilot and feasibility studies.

Definitions of feasibility outside the health research context focus on the likelihood of being able to do something. For example, the Oxford on-line dictionary defines feasibility as: ‘The state or degree of being easily or conveniently done’ [ 14 ] and a feasibility study as: ‘An assessment of the practicality of a proposed plan or method’ [ 15 ]. Some definitions also suggest that a feasibility study should help with decision making, for example [ 16 ]: ‘The feasibility study is an evaluation and analysis of the potential of a proposed project. It is based on extensive investigation and research to support the process of decision making’. Outside the health research context the word ‘pilot’ has several different meanings but definitions of pilot studies usually focus on an experiment, project or development undertaken in advance of a future wider experiment, project or development. For example the Oxford on-line dictionary describes a pilot study as: ‘Done as an experiment or test before being introduced more widely’ [ 17 ]. Several definitions carry with them ideas that the purpose of a pilot study is also to facilitate decision making, for example ‘a small-scale experiment or set of observations undertaken to decide how and whether to launch a full-scale project’ [ 18 ] and some definitions specifically mention feasibility, for example: ‘a small scale preliminary study conducted in order to evaluate feasibility’ [ 19 ].

In keeping with these definitions not directly related to the health research context, we agreed that feasiblity is a concept encapsulating ideas about whether it is possible to do something and that a feasibility study asks whether something can be done , should we proceed with it , and if so , how . While piloting is also concerned with whether something can be done and whether and how we should proceed with it, it has a further dimension; piloting is implementing something, or part of something, in a way you intend to do it in future to see whether it can be done in practice. We therefore agreed that a pilot study is a study in which a future study or part of a future study , is conducted on a smaller scale to ask the question whether something can be done , should we proceed with it , and if so , how . The corollary of these definitions is that all pilot studies are feasibility studies but not all feasibility studies are pilot studies. Within the context of RCTs, the focus of our research, the ‘something’ in the definitions can be replaced with ‘a future RCT evaluating the effect of an intervention or therapy’. Studies that address the question of whether the RCT can be done, should we proceed with it and if so how, can then be classed as feasibility or pilot studies. Some of these studies may, of course, have other objectives but if they are mainly focusing on feasiblity of the future RCT we would include them as feasiblity studies. All three studies used as examples in our Delphi survey [ 10 – 12 ] satisfy the definition of a feasiblity study. However, a study by Piot et al , that we encountered while developing the Delphi study, does not. This study is described as a pilot trial in the abstract but the authors present only data on effectiveness and although they state that their results require confirmation in a larger study it is not clear that their pilot study was conducted in preparation for such a larger study [ 20 ]. On the other hand, Palmer et al ‘performed a feasibility study to determine whether patient and surgeon opinion was permissive for a Randomised Controlled Trial (RCT) comparing operative with non-operative treatment for FAI [femoroacetabular impingement]’ [ 12 ]. Heazell et al describe the aim of their randomised study as ‘to address whether a randomised controlled trial (RCT) of the management of RFM [reduced fetal movement] was feasible’ [ 10 ]. Their study was piloting many of the aspects they hoped to implement in a larger trial of RFM, thus making this also a pilot study, whereas the study conducted by Palmer et al , which comprised a questionnare to clinicians and seeking patient opinion, is not a pilot study but is a feasibility study.

Within our framework, some important studies conducted in advance of a future RCT to evaluate the effect of a therapy or intervention are not feasibility studies. For example, a systematic review, usually an essential pre-requisite for such an RCT, normally addresses whether the future RCT is necessary or desirable , not whether it is feasible . To reflect this, we developed a comprehensive diagrammatical representation of our framework for studies conducted in preparation for an RCT which, for completeness, includes, on the left hand side, early studies that are not pilot and feasibility studies, such as systematic reviews and, along the bottom, details of existing or planned reporting guidelines for different types of study ( S2 Fig ).

Validating the conceptual framework—Systematic review

From the 150 most recent studies identified by our electronic search, we identified 27 eligible reports ( Fig 6 ). In keeping with our working definition of a pilot or feasibility study, to be included the reports had to show evidence that investigators were addressing at least some feasibility objectives and that the study was in preparation for a future RCT evaluating the effect of an intervention. Ideally we would have stipulated that the primary objective of the study should be a feasibility objective but, given the nature of the reporting of most of these studies, we felt this would be too restrictive.

The 27 studies are reported in Table 1 and results relating to terminology that authors used summarised in Table 2 . Results in Table 2 support our first hypothesis that the words ‘pilot’ and ‘feasibility’ are both used in the literature to describe studies undertaken in preparation for a randomised controlled trial of effectiveness; 63% (17/27) used both terms somewhere in the title or abstract. The table also supports our second hypothesis that amongst the subset of feasibility studies in preparation for an RCT that are themselves RCTs, authors do not use the term ‘pilot trial’ consistently in relation to these studies; of the 18 randomised studies only eight contained the words ‘pilot’ and ‘trial’ in the title. Our third hypothesis, namely that it is not possible to apply unique mutually exclusive definitions of pilot and feasibility studies in preparation for an RCT that are consistent with the way authors describe their studies, is supported by the characteristics of studies presented in Table 1 and summarised in Table 2 . We could find no design or other features (such as randomisation or presence of a control group) that distinguished between those that investigators called feasibility studies and those that they called pilot studies. However, the fourth hypothesis, that amongst studies in preparation for an RCT evaluating the effect of an intervention or therapy it is possible to identify some studies that explore the feasibility of a certain intervention or acquire related information about the feasibility of applying an intervention in a future study but are not pilot studies, was not supported; we identified no such studies amongst those reported in Table 1 . Nevertheless, we had identified two prior to carrying out the review [ 10 , 15 ].

Out of our exploratory sample of 30 study reports for which we reviewed full texts rather than only titles and abstracts, we identified 10 that could be classed as pilot or feasibility studies using our framework. We had already identified four of these in our sample reported in Table 1 , but had failed to identify the other six. As expected, this was because key information to identify them as pilot or feasiblity studies such as the fact that they were in preparation for a larger RCT, or that the main objectives were to do with feasiblity were not included in the abstract. Thus our assumption that an initial screen using only abstracts resulted in the omission of some pilot and feasiblity studies was correct.

International consensus meeting participants agreed with the general tenets of our conceptual framework including the ideas that all pilot studies are feasibility studies but that some feasibility studies are not pilot studies. They suggested that any definitive diagrammatic representation should more strongly reflect non-linearity in the ordering of feasibility studies. As a result of their input we produced a new, simplified, diagrammatical representation of the framework ( Fig 7 ) which focuses on the key elements represented inside an oval shape on our original diagram, omits the wider context outside this shape, and highlights some features, including the non-linearity, more clearly.

The finalised framework

Fig 7 represents the framework. The figure indicates that where there is uncertainty about future RCT feasibility, a feasibility study is appropriate. Feasibility is thus an overarching concept within which we distinguish between three distinct types of study. Randomised pilot studies are those studies in which the future RCT, or parts of it, including the randomisation of participants, is conducted on a smaller scale (piloted) to see if it can be done. Thus randomised pilot studies can include studies that for the most part reflect the design of a future definitive trial but, if necessary due to remaining uncertainty, may involve trying out alternative strategies, for example, collecting an outcome variable via telephone for some participants and on-line for others. Within the framework randomised pilot studies could also legitimately be called randomised feasibility studies. Two-thirds of the studies presented in Table 1 are of this type.

Non-randomised pilot studies are similar to randomised pilot studies; they are studies in which all or part of the intervention to be evaluated and other processes to be undertaken in a future trial is/are carried out (piloted) but without randomisation of participants. These could also legitimately be called by the umbrella term, feasibility study. These studies cover a wide range from those that are very similar to randomised pilot studies except that the intervention and control groups have not been randomised, to those in which only the intervention, and no other trial processes, are piloted. One-third of studies presented in Table 1 are of this type.

Feasibility studies that are not pilot studies are those in which investigators attempt to answer a question about whether some element of the future trial can be done but do not implement the intervention to be evaluated or other processes to be undertaken in a future trial, though they may be addressing intervention development in some way. Such studies are rarer than the other types of feasibility study and, in fact, none of the studies in Table 1 were of this type. Nevertheless, we include these studies within the framework because they do exist; the Palmer study [ 15 ] in which surgeons and patients were asked about the feasibility of randomisation is one such example. Other examples might be interviews to ascertain the acceptability of an intervention, or questionnaires to assess the types of outcomes participants might think important. Within the framework these studies can be called feasibility studies but cannot be called pilot studies since no part of the future randomised controlled trial is being conducted on a smaller scale.

Investigators may conduct a number of studies to assess feasibility of an RCT to test the effect of any intervention or therapy. While it may be most common to carry out what we have referred to as feasibility studies that are not pilot studies before non-randomised pilot studies , and non-randomised pilot studies prior to randomised pilot studies , the process of feasibility work is not necessarily linear and such studies can in fact be conducted in any order. For completeness the diagram indicates the location of internal pilot studies.

There are diverse views about the definitions of pilot and feasibility studies within the research community. We reached consensus over a conceptual framework for the definitions of these studies in which feasibility is an overarching concept for studies assessing whether a future study, project or development can be done. For studies conducted in preparation for a RCT assessing the effect of a therapy or intervention, three distinct types of study come under the umbrella of feasibility studies: randomised pilot studies, non-randomised pilot studies, feasibility studies that are not pilot studies. Thus pilot studies are a subset of feasibility studies. A review of the literature confirmed that it is not possible to apply mutually exclusive definitions of pilot and feasibility studies in preparation for such an RCT that are consistent with the way authors describe their studies. For example Lee et al [ 31 ], Boogerd et al [ 22 ] and Wolf et al [ 38 ] all describe randomised studies exploring the feasibility of introducing new systems (brain computer interface memory training game, on-line interactive treatment environment, bed-exit alarm respectively) but Lee et al describe their study as a ‘A Randomized Control Pilot Study’, with the word ‘feasibility’ used in the abstract and text, while the study by Boogerd et al . is titled ‘Teaming up: feasibility of an online treatment environment for adolescents with type 1 diabetes’, and Wolf at al describe their study as a pilot study without using the word ‘feasibility’.

Our re-evaluation of the definitions of pilot and feasibility studies was conducted over a period of time with input via a variety of media by multi-disciplinary and international researchers, publishers, editors and funders. It was to some extent a by-product of our work developing reporting guidelines for such studies. Nevertheless, we were able to gather a wide range of expert views, and the iterative nature of the development of our thinking has been an important part of obtaining consensus. Other parallel developments, including the recent establishment of the new Pilot and Feasibility Studies journal [ 48 ], suggest that our work is, indeed, timely. We encountered several difficulties in reviewing empirical study reports. Firstly, it was sometimes hard to assess whether studies were planned in preparation for an RCT or whether the authors were conducting a small study and simply commenting on the fact that a larger RCT would be useful. Secondly, objectives were sometimes unclear, and/or effectiveness objectives were often emphasised in spite of recommendations that pilot and feasibility studies should not be focusing on effectiveness [ 1 , 4 ]. In identifying relevant studies we erred on the side of inclusiveness, acknowledging that getting these studies published is not easy and that there are, as yet, no definitive reporting guidelines for investigators to follow. Lastly, our electronic search was unable to identify any feasibility studies that were not pilot studies according to our definitions. Subsequent discussion with qualitative researchers suggested that this is because such studies are often not described as feasibility studies in the title or abstract.

Our framework is compatible with the UK MRC guidance on complex interventions which suggests a ‘feasibility and piloting’ phase as part of the work to design and evaluate such interventions without any explicit distinction between pilot and feasibility studies. In addition, although our framework has a different underlying principle from that adopted by UK NIHR, the NIHR definition of a pilot study is not far from the subset of studies we have described as randomised pilot studies. Although there appears to be increasing interest in pilot and feasibility studies, as far as we are aware no other funding bodies specifically address the nature of such studies. The National Institute for Health in the USA does, however, routinely require published pilot studies before considering funding applications for certain streams, and the Canadian Institutes of Health Research routinely have calls for pilot or feasibility studies in different clinical areas to gather evidence necessary to determine the viability of new research directions determined by their strategic funding plans. These approaches highlight the need for clarity regarding what constitutes a pilot study.

There are several previous reviews of empirical pilot and feasibility studies [ 1 , 4 , 7 ]. In the most recent, reviewing studies published between 2000 and 2009 [ 7 ], the authors identified a large number of studies, described similar difficulty in identifying whether a larger study was actually being planned, and similar lack of consistency in the way the terms ‘pilot’ and ‘feasibility’ are used. Nevertheless, in methodological work, many researchers have adopted fairly rigid definitions of pilot and feasibility studies. For example, Bugge et al in developing the ADEPT framework refer to the NIHR definitions and suggest that feasibility studies ask questions about ‘whether the study can be done’ while pilot trials are ‘(a miniature version of the main trial), which aim to test aspects of study design and processes for the implementation of a larger main trial in the future’ [ 49 ]. Although not explicitly stated, the text seems to suggest that pilot and feasibility studies are mutually exclusive. Our work indicates that this is neither necessary nor desirable. There is, however, general agreement in the literature about the purpose of pilot and feasibility studies. For example, pilot trials are ‘to provide sufficient assurance to enable a larger definitive trial to be undertaken’ [ 50 ], and pilot studies are ‘designed to test the performance characteristics and capabilities of study designs, measures, procedures, recruitment criteria, and operational strategies that are under consideration for use in a subsequent, often larger, study’ [ 51 ], and ‘play a pivotal role in the planning of large-scale and often expensive investigations’ [ 52 ]. Within our framework we define all studies aiming to assess whether a future RCT is do-able as ‘feasibility studies’. Some might argue that the focus of their study in preparation for a future RCT is acceptability rather than feasibility, and indeed, in other frameworks, such as the RE-AIM framework [ 53 ], feasibility and acceptability are seen as two different concepts. However, it is perfectly possible to explore the acceptability of an intervention, of a data collection process or of randomisation in order to determine the feasibility of a putative larger RCT. Thus the use of the term ‘feasibility study’ for a study in preparation for a future RCT is not incompatible with the exploration of issues other than feasibility within the study itself.

There are numerous previous studies in which the investigators review the literature and seek the counsel of experts to develop definitions and clarify terminology. Most of these relate to clinical or physiological definitions [ 54 – 56 ]. A few explorations of definitions relate to concepts such as quality of life [ 57 ]. Implicit in much of this work is that from time to time definitions need rethinking as knowledge and practice moves on. From an etymological point of view this makes sense. In fact, the use of the word ‘pilot’ to mean something that is a prototype of something else only appears to emerge in the middle of the twentieth century and the first use of the word in relation to research design that we could find was in 1947—a pilot survey [ 58 ]. Thus we do not have to look very far back to see changes in the use of one of the words we have been dealing with in developing our conceptual framework. We hope what we are proposing here is helpful in the early twenty-first century to clarify the use of the words ‘pilot’ and ‘feasibility’ in a health research context.

We suggest that researchers view feasibility as an overarching concept, with all studies done in preparation for a main study open to being called feasibility studies, and with pilot studies as a subset of feasibility studies. All such studies should be labelled ‘pilot’ and/or ‘feasibility’ as appropriate, preferably in the title of a report, but if not certainly in the abstract. This recommendation applies to all studies that contribute to an assessment of the feasibility of an RCT evaluating the effect of an intervention. Using either of the terms in the title will be most helpful for those conducting future electronic searches. However, we recognise that for qualitative studies, authors may find it convenient to use the terms in the abstract rather than the title. Authors also need to describe objectives and methods well, reporting clearly if their study is in preparation for a future RCT to evaluate the effect of an intervention or therapy.

Though the focus of this work was on the definitions of pilot and feasibility studies and extensive recommendations for the conduct of these studies is outside its scope, we suggest that in choosing what type of feasibility study to conduct investigators should pay close attention to the major uncertainties that exist in relation to trial or intervention. A randomised pilot study may not be necessary to address these; in some cases it may not even be necessary to implement an intervention at all. Similarly, funders should look for a justification for the type of feasibility study that investigators propose. We have has also highlighted the need for better reporting of these studies. The CONSORT extension for randomised pilot studies that our group has developed are important in helping to address this need and will be reported separately. Nevertheless, further work will be necessary to extend or adapt these reporting guidelines for use for non-randomised pilot studies and for feasibility studies that are not pilot studies. There is also more work to be done in developing good practice guidance for the conduct of pilot and feasibility studies.

Supporting Information

Acknowledgments.

We thank Alicia O’Cathain and Pat Hoddinot for discussions about the reporting of qualitative studies, and consensus participants for their views on our developing framework. Claire Coleman was funded by a National Institute for Health Research (NIHR) Research Methods Fellowship. This article presents independent research funded by the NIHR. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.

Funding Statement

The authors received small grants from Queen Mary University of London (£7495), University of Sheffield (£8000), NIHR RDS London (£2000), NIHR RDS South East (£2400), Chief Scientist Office Scotland (£1000). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Data Availability