Patient Recruitment
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.
Modern recruitment strategies blend site-centric channels (PI referrals, site outreach, EHR mining) with sponsor-centric channels (digital advertising, registries, patient advocacy partnerships) and AI-driven channels (eligibility matching against EHR networks). Each channel is tracked by funnel metrics: reach, engagement, prescreen, screen, randomized.
FDA's 2022 Diversity Plan guidance now requires sponsors to submit Race and Ethnicity Diversity Plans for pivotal trials, which the recruitment strategy must operationalize through site selection, language access, and community-engaged outreach.
Related terms
Patient Recruitment (Clinical Trials)
Patient recruitment is the end-to-end process of identifying, contacting, screening, and enrolling participants in a clinical trial, encompassing site-driven outreach, central recruitment campaigns, EHR-based identification, and patient-engagement workflows.
Patient Pre-screening
Patient pre-screening is the process of evaluating individuals against a clinical trial's inclusion and exclusion criteria, before formal screening visits, to identify likely-eligible candidates and reduce screen failure rates.
Diversity in Clinical Trials
Diversity in clinical trials is the inclusion of participants representing the demographic, racial, ethnic, age, sex, and socioeconomic populations expected to use the investigational product after approval, ensuring efficacy and safety findings generalize to the real-world patient population.
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.
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