Self-Study 2026: Bias in Clinical Trial Enrollment: Addressing Disparities in Underserved Populations

Clinical trials drive progress in cancer care, yet participation in research is not equitably distributed. Many patients never learn about relevant studies, live too far from trial sites, or are excluded by eligibility criteria that may not reflect contemporary oncology practice.

This self-study examines how bias enters clinical trial enrollment through protocol design, site selection, and operational decisions, and reviews practical evidence-informed strategies to address these barriers within U.S.-based oncology research. Learners will explore current literature and regulatory guidance related to eligibility reform, geographic access, social vulnerability, and Diversity Action Plans. The goal of this activity is to equip learners with tools to identify and mitigate sources of bias in trial design and operations. These strategies aim to improve the representativeness of enrolled participants so that trial findings are more applicable to the intended treatment populations in clinical practice.