Patient Recruitment
Enrollment Rate
Enrollment rate is the average number of participants randomized per active site per month in a clinical trial, used as the principal operational metric of recruitment performance.
Industry benchmarks vary by therapeutic area: oncology Phase 2 trials average 0.5; 1.5 patients per site per month; cardiovascular Phase 3 may exceed 5. Underperforming sites (those below half the median) are the leading cause of trial delays; ~37% of selected sites under-enroll and 11% never enroll a patient (Tufts CSDD).
Enrollment rate is tracked weekly against the recruitment curve; deviations trigger rescue strategies including site augmentation, additional country activation, or protocol amendments.
Related terms
Site Selection (Clinical Trials)
Site selection is the process by which sponsors and CROs identify, evaluate, and choose the clinical trial sites best suited to enroll a given study, based on patient population access, investigator experience, operational capacity, regulatory standing, and historical performance.
Patient Recruitment Strategy
A patient recruitment strategy is the documented, multi-channel plan a sponsor or CRO uses to identify, engage, screen, and enroll the participants required to meet a clinical trial's enrollment timeline, sample size, and diversity goals.
Feasibility Assessment
A feasibility assessment is a structured evaluation of whether a planned clinical trial can recruit enough eligible patients, at qualified sites, within the required timeline and budget, given a specific protocol design.
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