How to Design a Successful Feasibility Study in Clinical Trials

A feasibility study is one of the most crucial pre-trial planning tools in clinical research. It determines whether a proposed clinical trial is practical, scientifically sound, financially viable, and ethically justified. Unfortunately, many sponsors and research teams underestimate its power—resulting in delayed site activations, under-enrollment, protocol amendments, and, ultimately, trial failure.

This guide explains how to design a successful feasibility study, emphasizing best practices, strategic objectives, and real-world implementation. Based on insights from The Ultimate Guide to Clinical Trials: A Complete Handbook for Researchers and Practitioners, this blog post supports the mission of clinicaltrialshandbook.com: to equip clinical trial professionals with tools for precision, compliance, and performance.

What Is a Feasibility Study in Clinical Trials?

A clinical trial feasibility study is a structured assessment conducted before launching a trial. Its goal is to evaluate whether the proposed study can be executed successfully given the protocol requirements, available patient population, regulatory environment, budget, and operational resources.

A feasibility study should assess:

• Protocol complexity

• Site capability and interest

• Investigator availability

• Patient access and eligibility

• Competing studies

• Logistics and timelines

• Budget alignment

Why Feasibility Studies Matter

Feasibility studies are the bridge between concept and execution. They reduce uncertainty and help sponsors and CROs make informed go/no-go decisions.

Benefits include:

• Identifying patient recruitment barriers early

• Preventing unrealistic timelines and budgets

• Selecting high-performing research sites

• Detecting regulatory and ethical approval challenges

• Optimizing protocol design before IRB submission

According to industry benchmarks, 80% of clinical trials fail to meet enrollment targets on time. Most of these failures could have been predicted—and mitigated—by a proper feasibility study.

Key Components of a Feasibility Study

A successful feasibility study includes several interrelated assessments:

1. Scientific and Protocol Feasibility

• Are the inclusion/exclusion criteria realistic?

• Are endpoints measurable within the proposed timeline?

• Is the intervention supported by preclinical/early phase data?

• Are procedures overly invasive or burdensome?

2. Operational Feasibility

• Can the sites manage the visit schedule, testing requirements, and data collection?

• Do the sites have the necessary equipment and staff?

• Are appropriate SOPs and quality assurance systems in place?

3. Regulatory and Ethical Feasibility

• What is the IRB/EC turnaround time?

• Are there country-specific regulatory hurdles?

• Is the trial design in line with local GCP and data privacy regulations?

4. Financial Feasibility

• Is the sponsor budget aligned with site cost expectations?

• Are there pass-through costs, courier fees, or other hidden expenses?

• Will sites be reimbursed in a timely manner?

5. Patient Access and Enrollment Feasibility

• Does the site have access to the target patient population?

• What are the predicted screen failure and dropout rates?

• Are there competing trials in the same therapeutic area?

How to Conduct a Feasibility Study: Step-by-Step

1. Define Study Objectives and Scope

   • Clarify therapeutic area, phase, population, and geographic regions

   
   

2. Develop a Feasibility Questionnaire

   • Include questions on recruitment history, staffing, equipment, regulatory experience, and protocol-specific needs

   
   

3. Distribute Questionnaire to Target Sites

   • Engage with a select list of potential sites (use previous performance data where available)

   
   

4. Conduct Follow-Up Interviews

   • Schedule calls to clarify responses and assess site enthusiasm, experience, and communication style

   
   

5. Analyze and Score Responses

   • Use a scoring matrix to rank sites based on key performance indicators (KPIs) and risk

   
   

6. Validate with Site Data

   • Compare site claims with historical data (from CTMS, registries, or prior studies)

   
   

7. Generate a Feasibility Report

   • Summarize risks, opportunities, site recommendations, and next steps

   
   

8. Make Informed Go/No-Go and Site Selection Decisions

Tools and Technology for Feasibility Assessment

Modern platforms and software can streamline the feasibility process:

• CTMS platforms (e.g., Veeva, Medidata, Oracle Clinical One)

• Feasibility intelligence tools (e.g., Citeline, TrialScope, TriNetX)

• Electronic feasibility surveys with automated scoring

• Patient population analytics tools using EHR or claims data

Tip from My Book: Integrate feasibility tools early in your site identification workflow for optimal alignment with study timelines.

Common Mistakes in Feasibility Studies (And How to Avoid Them)

• Relying on site enthusiasm over data

• Ignoring competing studies

• Using generic, one-size-fits-all questionnaires

• Underestimating regulatory delays

• Overlooking protocol design flaws

• Failing to engage sites in realistic enrollment forecasting

Prevention Strategy:

Design tailored feasibility tools for each protocol and involve cross-functional stakeholders early—regulatory, medical, operational, and financial.

Conclusion: Feasibility is the Trial’s First Risk Filter

A well-designed feasibility study is not a luxury—it is a necessity. It aligns science with operational capability and ensures every trial is built on a solid, data-driven foundation. Designing and executing feasibility correctly reduces costly amendments, boosts enrollment success, and positions your study for regulatory approval.

As a clinical trial expert and author of The Ultimate Guide to Clinical Trials, I provide detailed feasibility checklists, site evaluation templates, and scorecard frameworks that can transform your planning process. For those seeking to reduce risk and increase trial execution confidence, a robust feasibility study is your starting line.