Patient Recruitment
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.
Under FDORA (2022) and FDA's 2024 Diversity Action Plan guidance, sponsors of most pivotal Phase 3 trials must submit Diversity Action Plans defining enrollment goals by race, ethnicity, age, and sex, plus operational measures to achieve them. EMA's 2024 reflection paper sets parallel European expectations.
Operational tactics include targeted site selection in diverse catchment areas, multi-language consent, transportation and childcare support, and partnerships with community health organizations.
References
Related terms
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.
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 (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.
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