Protocol feasibility assessment exists to catch these problems before they cost you money. It's a proactive review, conducted before study activation, not a post-mortem after a site has burned through its startup budget with no patients enrolled.
This guide covers what feasibility assessment actually means, the operational risks it uncovers, and a step-by-step process sponsors can use to run one.
Key Takeaways
- Protocol feasibility catches logistical, financial, and accrual risk before IRB or ethics review begins
- Early assessment makes staffing gaps, budget shortfalls, and thin patient pools predictable and preventable
- Structured multidisciplinary review reduces protocol amendments and site underperformance
- CRO partners supply site intelligence and cross-functional expertise internal teams often lack
What Is Protocol Feasibility Assessment?
Protocol feasibility is an early-stage review of whether a trial can realistically be conducted, on time and on budget, in a given setting. It looks at logistics, cost, and patient availability before the protocol goes to scientific or ethics review.
Think of it like the stage-gate model used in R&D investment decisions: each gate filters out low-probability projects early so resources go to programs likely to succeed. In clinical trials, that means stress-testing a protocol's practicality before you commit site budgets and staff time.
How Feasibility Differs from Site Selection and IRB Review
These three steps are often confused, but they answer different questions:
- Protocol feasibility asks: can this study, as designed, realistically be executed?
- Site selection asks: which specific sites are best suited to run it?
- IRB review asks: is this study ethically sound and scientifically justified?
Feasibility comes first. Ethics-committee requirements and translation needs are inputs into the feasibility review, not a substitute for it.
Types of Feasibility Reviewed
Sponsors structuring a feasibility checklist typically assess four categories:
- Logistical feasibility – staff, equipment, facility access
- Financial feasibility – true costs versus proposed reimbursement
- Accrual/recruitment feasibility – realistic patient availability
- Regulatory feasibility – approval timelines and compliance requirements
Core Operational Risks to Identify Before Study Start
Logistical Risk
Does the site have the bandwidth to run this protocol? Assess:
- Investigator experience with similar studies
- Equipment and facility access
- Subcontractor capacity (labs, imaging centers) against the protocol timeline
A visit schedule that looks fine on paper can overwhelm a coordinator already managing four other active trials.
Financial Risk
Sponsor reimbursement rarely matches true site costs. Hidden costs that get missed during budget planning include:
- Adverse event reporting workload, including immediate serious AE notification to sponsors per FDA safety-reporting guidance
- Patient travel support (a 2018 UCSF study found cancer-trial patients traveled a median of 25.8 miles one-way; 39.4 miles for NIH-sponsored trials)
- Staff overtime for visit-heavy protocols
- Data management and query resolution time
Underestimating any of these categories is a common driver of mid-study budget renegotiations.
Accrual/Recruitment Risk
Screen-fail rates vary widely by study and are not standardized industry-wide. A 2014 analysis of the POINT trial found fewer than 5% of 27,292 screened patients were ultimately enrolled.
Other single-study audits report screen-fail rates from 23% to 51%, depending on population and criteria. Sponsors need realistic screen-fail models for this protocol rather than optimistic screened-to-enrolled conversion assumptions.
Competing trials targeting the same patient population compound this risk, especially in narrow indications.
Regulatory/Ethical Risk
Local approval timelines vary by country and site. A protocol that assumes uniform startup speed across regions will hit delays somewhere. Layer in competing studies drawing from the same investigator pool, and activation timelines can slip well past initial projections.
Underestimating any single risk category rarely stays contained. It tends to surface later as a costly protocol amendment.
One review found that 16% of protocol amendments stem from inclusion/exclusion criteria changes, and more than 40% of trials are amended before the first patient visit ever occurs, adding roughly four months to timelines, according to a 2018 review of clinical trial failure factors.
7 Steps to Conducting a Protocol Feasibility Study
- Assemble a multi-disciplinary review group. Include biostatisticians, medical monitors, clinical operations staff, data managers, and investigators with relevant experience.
- Review protocol design against site capabilities. Compare visit frequency, procedures, and patient burden to what sites can realistically deliver.
- Conduct a financial feasibility analysis. Compare the draft budget line-by-line against true site and study costs, including hidden and indirect costs that draft budgets often miss.
- Evaluate accrual feasibility. Use historical enrollment data, expected screen-fail rates, and competing trial activity in the target population.
- Identify regulatory and logistical red flags. Focus on approval timelines and market-specific compliance requirements in each target region.
- Document findings in a formal feasibility report. Include mitigation recommendations for each identified risk.
- Make a go/no-go or refine-and-resubmit decision. Do this before committing to full activation, not after.
This process works because it forces disagreements to surface early. A biostatistician flagging an unrealistic enrollment target in week two costs nothing. The same flag raised after six months of slow recruitment costs real money.
Common Red Flags That Signal a Study Is Not Feasible
Watch for these warning signs during review:
- Overestimated patient pools that don't account for inclusion/exclusion narrowing or patient willingness to participate
- Investigator or site history showing repeated missed accrual goals on past studies
- Protocol demands (visit frequency, procedure count, or data collection burden) that exceed what staff can realistically manage within the proposed timeline
A well-known case: the STICH heart-failure trial expanded from 32 US/Canada sites to 171 international sites after low enrollment. Forty-four approved sites enrolled zero patients, at an estimated $10,000 cost per deactivated site. The funding shortfall forced cuts to planned imaging studies—an avoidable hit when feasibility review is skipped.
Strong site signals are measurable, not guesswork. Research-focused sites were 41% better enrollers than sites primarily focused on clinical practice. Sites running 6–10 trials were also more likely to hit enrollment timelines, per Applied Clinical Trials' site-performance research.
Why Sponsors Partner with a CRO for Protocol Feasibility
Internal-only feasibility reviews have a blind spot: they're evaluated by the same team invested in the study moving forward. A CRO with a global footprint and cross-functional in-house expertise can stress-test protocols with more objectivity and broader site intelligence than a sponsor working alone.
Independent CRO feasibility support typically strengthens:
- Objectivity free from internal pressure to green-light the protocol
- Cross-functional review across operations, regulatory, and data teams
- Site intelligence drawn from multi-regional networks
DRK Research Solutions operates as an end-to-end CRO across Phase II–IV trials, with regional teams across Europe, the Middle East, Asia, Africa, and the Americas. That footprint matters most for accrual and regulatory feasibility. Approval timelines and patient population dynamics look different in Lahore than they do in Cambridge or Aldie, Virginia.
Assessing feasibility without that localized context leaves gaps that surface later—usually as amendments or delays. The practical value is on-the-ground experience with how a region's regulatory bodies actually move, not only how the guidelines say they should.
Frequently Asked Questions
What are protocols in clinical trials?
A clinical trial protocol is the formal document describing a study's objectives, design, methodology, statistical considerations, and organization. It's the blueprint sponsors, sites, and regulators work from.
What are the 5 major components of a feasibility study?
Site readiness, prior study experience, protocol requirement fit, investigator input, and access to the target patient population. Each one shapes whether a study can realistically be delivered as designed.
What are the 4 types of feasibility?
Logistical, financial, accrual/recruitment, and regulatory feasibility. Sponsors typically assess all four before moving a protocol toward activation.
What are the 7 steps in conducting a feasibility study?
Assemble a review team, assess protocol-site fit, run financial analysis, evaluate accrual potential, flag regulatory issues, document findings, and make a go/no-go decision. Complete them in order so findings compound into a clear go/no-go call.
How early should protocol feasibility review happen?
It should happen before IRB/PRMC review and before resource-intensive activation steps begin. Running it later defeats the purpose: risks should be caught before money and time are committed.
What happens if a study is found not feasible?
Sponsors typically choose between refining the protocol, reselecting sites, or delaying activation until conditions improve. None of these are failures; they're far cheaper than discovering the same problems mid-study.
