What Is a Feasibility Study in Clinical Trials

Before you ever recruit a participant or collect a data point, there’s one critical step that sets your clinical trial up for success: the feasibility study. It’s not the flashiest part of the research process, but it’s easily one of the most important.

Think of it as the blueprint for your trial. Without it, you're essentially guessing. With it, you're building on solid ground, with fewer surprises, fewer delays, and far less wasted budget. In this post, we’ll explore what a feasibility study is, why it matters, and how it can turn a good clinical trial into a great one.

What Is a Feasibility Study?

A feasibility study is a pre-trial evaluation designed to assess whether your proposed clinical study is achievable, scientifically, logistically, and financially. It’s a crucial phase that examines:

• Study objectives and endpoints

• Participant availability and recruitment potential

• Timeline and resource requirements

• Site or investigator capabilities

• Budget constraints

• Potential barriers and risks

The goal? To reduce uncertainty and maximize the chances that your study runs smoothly from start to finish.

Why Is a Feasibility Study Important for Clinical Trials?

Whether you’re validating claims, pursuing third-party certification, or just building consumer trust, a feasibility study helps ensure your clinical trial is doable, defensible, and worth the investment.

Here’s why it matters:

1. Reduces Risk and Wasted Resources

A feasibility study highlights red flags early, like difficult-to-recruit populations, overly ambitious timelines, or insufficient site capabilities. Identifying these early prevents costly mid-trial surprises.

2. Improves Trial Design and Protocols

Not sure which endpoints are measurable? Wondering how many participants you realistically need? The feasibility study helps refine your study protocol so that it aligns with both scientific standards and operational reality.

3. Enhances Credibility

Clinical trials are often used to support “clinically tested” or “clinically proven” claims. A well-executed feasibility study boosts credibility with research partners, regulatory reviewers, and even skeptical consumers.

4. Streamlines Budgeting and Resource Allocation

By modeling your trial before it starts, you’ll have a clearer picture of actual costs, staffing needs, and technology requirements, making it easier to allocate resources wisely.

What’s Included in a Feasibility Study?

While the exact components can vary, a comprehensive feasibility study usually includes:

Component	Description
Study Objectives	Define what the trial aims to prove and how success will be measured.
Target Population Analysis	Evaluate the size, accessibility, and willingness of the participant pool.
Site Selection	Assess research sites or CROs for experience, capacity, and alignment with the study.
Recruitment Feasibility	Identify recruitment strategies, barriers, and timelines.
Budget Planning	Create a realistic financial model for the full study lifecycle.
Regulatory Considerations	Account for necessary IRB/ethics review and compliance needs.
Timeline Projections	Map out a practical timeline from initiation to final reporting.
Risk Assessment	Anticipate potential challenges and create contingency plans.

When Should You Conduct a Feasibility Study?

The ideal time to conduct a feasibility study is before finalizing your study protocol or signing contracts with research sites or CROs. Why?

Because once the wheels are in motion, course correction becomes costly. A feasibility study ensures your trial is based on validated assumptions, not guesswork, and that you’re prepared for whatever challenges lie ahead.

Who Conducts a Feasibility Study?

Feasibility studies are often conducted by contract research organizations (CROs), study sponsors, or in some cases, third-party consultants with expertise in clinical operations. If you're working with a CRO, they may offer feasibility assessments as part of their early-phase services.

However, not all feasibility studies are created equal. Look for partners that understand both your product category and target population, as this insight can make or break the success of your trial.

Common Mistakes Brands Make Without a Feasibility Study

Skipping a feasibility study can lead to:

• Underestimating recruitment time, delaying your trial by months

• Overspending due to poor budget forecasting

• Choosing the wrong sites, leading to protocol deviations or high dropout rates

• Unclear endpoints, resulting in inconclusive or non-marketable results

Brands that skip this step often end up running a second trial to fix the mistakes of the first, doubling their cost and timeline.

Why Every Trial Starts with a Feasibility Study

In clinical research, planning is everything. A feasibility study may seem like a delay at the outset, but in reality, it accelerates everything that comes after. It empowers you to make informed decisions, avoid costly missteps, and launch a clinical trial that actually delivers.

If you’re serious about evidence-backed product claims and want a study that finishes on time, on budget, and on target, a feasibility study isn’t optional. It’s essential.

Need help conducting a clinical study?

We offer custom, affordable assessments tailored to your product and audience. Let’s set your study up for success, get in touch today.