Feasibility Study Design

Feasibility study design evaluates clinical trial operational viability including patient recruitment capacity, protocol adherence, and safety monitoring systems prior to full-scale trial launch. Pilot studies enrol limited patient numbers at subset sites assessing baseline data, eligibility criteria appropriateness, and outcome measure validity. Feasibility metrics including enrolment rates, protocol deviation frequencies, and data quality assessments quantify trial operational readiness. Risk-identified areas undergo protocol refinement before main trial initiation.

Feasibility studies employ adaptive approaches permitting protocol modifications based on pilot findings. Site performance assessment identifies high-performing and struggling sites informing main trial site selection. Investigator training programmes address identified knowledge gaps improving subsequent trial conduct. Patient preference assessment through feasibility studies informs endpoint selection and study burden optimisation. Regulatory guidance increasingly emphasises feasibility assessment reducing full-scale trial failures. Efficient feasibility study conduct balances comprehensive assessment against timeline pressures.