Broadening Eligibility Criteria And Diversity Among Patients For Cancer Clinical Trials

Despite significant U.S. investments in clinical research, certain populations remain underrepresented in clinical trials, limiting the generalizability of findings. To address this, the FDA drafted guidance on Race and Ethnicity Diversity Action Plans in clinical trials, as mandated by 2022 federal legislation. However, the impact of broadening eligibility criteria on sociodemographic diversity remains unclear. This study assessed the effect of broadened eligibility criteria on the diversity of cancer patients eligible for clinical trials using a nationwide electronic health record-derived de-identified database.  Explore the results and the conclusion that data-driven evaluation of clinical trial eligibility criteria may optimize the inclusion of historically underrepresented groups.