Before a single participant is enrolled or a protocol is submitted for ethics approval, one critical document quietly shapes the course of a clinical trial: the Clinical Research Feasibility Assessment (CRFA). Often developed during the earliest planning stages, a CRFA evaluates whether a clinical trial can, and should, be conducted. It combines scientific insight with operational logistics, offering a practical blueprint for execution while identifying potential roadblocks that could derail the study.
In this article, we explore the essential components of a CRFA, its role in reducing trial risk, and how it helps sponsors make informed decisions that lead to successful, efficient, and compliant clinical research.
What’s Included in a CRFA?
A robust CRFA is structured to cover the full spectrum of trial planning, from scientific rationale to logistical readiness. Below is a typical outline of what’s included in a comprehensive feasibility assessment:
- Executive Summary / Overview
A concise summary of the study’s objectives, relevance, and anticipated outcomes. This section offers a high-level view of the proposed trial and serves as an accessible entry point for decision-makers.
- Introduction / Background
Provides clinical context for the study, including a description of the condition under investigation, current treatment landscape, and scientific rationale for the new intervention. This framing is critical for understanding the need and potential impact of the trial.
- Study Objectives / Goals
Clearly defines what the study aims to achieve. Objectives are typically divided into primary and secondary endpoints and are aligned with the study’s central research questions around efficacy, safety, or comparative performance.
- Study Design and Methodology
Details the proposed structure of the trial, including its classification (e.g., randomized controlled trial, open-label study), blinding and randomization techniques, and inclusion/exclusion criteria. The design is crafted to ensure scientific rigor and regulatory alignment.
- Sample Size Calculation / Power Analysis
Offers statistical justification for the proposed sample size, ensuring that the study is adequately powered to detect meaningful differences between treatment groups. This section is grounded in anticipated effect size, variability, and acceptable levels of significance and power.
- Study Intervention and Visit Schedule / Treatment Plan
Outlines the investigational product(s), dosing regimen, and visit schedule. This includes all planned procedures, assessments, and timelines, helping assess the burden on participants and study sites.
- Endpoints Measurement and Assessments
Describes how efficacy and safety will be measured throughout the trial. The endpoints must be clinically relevant, measurable, and aligned with regulatory expectations.
- Clinical Trial Site Requirements
Identifies the operational capabilities needed at study sites, such as equipment, staffing, and infrastructure. This section helps determine whether proposed sites are suitable and what support they may need.
- Regulatory and Ethical Considerations / Compliance
Summarizes the applicable regulatory pathways and ethical review requirements, including considerations for GCP compliance, informed consent, and country-specific authorizations.
- Safety Monitoring / Participant Safety
Details the plan for ongoing safety oversight, including procedures for reporting and managing adverse events. This ensures participant welfare is prioritized throughout the study.
- Data Management / Electronic Data Capture (EDC) / Data Handling
Describes the systems and workflows for collecting, storing, and analyzing trial data. Topics include EDC platforms, data integrity checks, and data privacy compliance.
- Potential Challenges and Mitigation Strategies / Risk Management
Anticipates risks—such as recruitment delays, protocol deviations, or logistical hurdles—and provides proactive strategies to manage or avoid them.
- Impact and Dissemination / Outreach
Discusses how the results will be communicated, including publication plans, conference presentations, or stakeholder updates. This ensures that the trial’s findings reach the appropriate audiences.
- Budget and Resources / Financial Plan
Breaks down projected costs and resource needs, from site fees to data management. Budget planning helps sponsors evaluate whether the study is financially viable.
- Timeline / Project Schedule
Maps out the full lifecycle of the study, including key milestones like start-up, recruitment, data lock, and final reporting.
- References
Cites supporting literature, regulatory guidance, and prior research that inform the design and methodology of the trial.
- Presentation of dicentra / Company Profile
Provides an overview of dicentra’s experience and capabilities, highlighting our role in helping sponsors bring clinical trials from concept to completion.
Why CRFAs Matter
Feasibility assessments aren’t just bureaucratic paperwork, they are foundational to clinical research success. By capturing both scientific and logistical insights, CRFAs help identify challenges before they occur and ensure that the trial is properly scoped, resourced, and executable.
A well-prepared CRFA allows sponsors to:
- Validate whether a trial is scientifically and operationally feasible
- Make informed decisions on proceeding with or modifying a proposed study
- Align expectations among stakeholders early in the planning process
- Reduce the risk of costly delays, amendments, or trial failure
At a time when clinical trials are becoming more complex and competitive, a strong feasibility assessment offers a clear strategic advantage. It sets the stage for trials that are not only compliant and well-powered but also achievable within timelines and budgets.
By starting with a CRFA, sponsors give their clinical programs the structure, foresight, and clarity they need to succeed. As a trusted partner in clinical research, dicentra ensures that every assessment reflects the highest standards of scientific integrity and operational excellence.
