Protocol Development and Feasibility
Protocol development translates a scientific question into an executable, ethical, and statistically sound plan. Candidates must understand the standard protocol sections - background and rationale, objectives and endpoints, study design, eligibility criteria, interventions, assessments and schedule of activities, statistics, safety reporting, and ethics - and how they interlock. A mismatch between an objective and its endpoint, or between an endpoint and the schedule of activities, is a classic design flaw.
Core concepts include primary versus secondary endpoints, inclusion/exclusion criteria, randomization and blinding, control selection, sample size drivers, adaptive designs, and feasibility assessment. Feasibility is not just "can we enroll?" - it covers site capability, competing trials, patient prevalence, recruitment and retention rates, operational burden of assessments, and country mix.
Traps: confusing an objective with an endpoint; treating a surrogate endpoint as a clinical outcome; writing eligibility criteria so restrictive that enrollment becomes infeasible; and overlooking that the schedule of activities drives both site burden and cost. Another frequent trap is a question that presents a statistically valid design that is operationally impossible - the best answer balances both.
Rule of thumb: every assessment in the schedule of activities should map to an objective, and every objective should map to at least one endpoint. If it doesn't map, question why it's there.
Worked example: A protocol adds a monthly MRI "for safety" but no objective or endpoint references imaging, and the site has no MRI. The feasibility review should flag the operational burden and propose removing or justifying the assessment before finalization.