Considering Modifications to Existing FDA Regulatory Incentives to Achieve Greater Racial and Ethnic Diversity in Pivotal Clinical Trials for Drug Approvals

Sarah Thompson Schick & Kirsten Axelsen


When clinical trials for new drug approvals fail to adequately represent racial and ethnic groups, there is a lost opportunity to collect data on people who will be prescribed these medications. In this Paper, we consider data published by the U.S. Food and Drug Administration reflecting the current state of diversity in pivotal clinical trials, which establish the safety and efficacy data to be considered for drug approval. We offer recommendations based on the information revealed in these data, which show a persistent under-representation of diverse populations in pivotal trials despite decades of guidance and proposed actions intended to achieve greater diversity.