Racial and Ethnic Representation in US Clinical Trials of New Drugs and Biologics, 2015-2019
Milena Lolic, Richardae Araojo, Melvyn Okeke, Janet Woodcock
Abstract
Concerns have been raised over racial and ethnic representation in clinical trials. In 2015, the US Food and Drug Administration (FDA) launched the Drug Trials Snapshots program, a transparency initiative highlighting demographics in the pivotal clinical trials that supported FDA approval of new molecular entities or original biologics. Recently, the FDA published a summary report of aggregated global demographic data from the trials that were the basis for snapshots published between 2015 and 2019. 1 Using that database, we reviewed the participation of racial and ethnic populations at US sites to understand the extent to which US trial participation represents the diversity of the US population.