Diversity in clinical trials: an opportunity and imperative for community engagement

Abstract

Enhancing clinical trial diversity is a moral and scientific imperative. The lack of diversity is an obstacle to understanding the safety and efficacy of novel therapies across population subgroups, which is crucial to reducing disparities and advancing equity. Furthermore, the striking and persistent under-representation of minority racial and ethnic groups in clinical trials is harmful. In the USA, minority racial and ethnic groups comprise nearly 40% of the population; however, 75% of the 32 000 participants in the trials of 53 novel drugs approved in 2020 by the US Food and Drug Administration (FDA) were White.