The FDA Race And Ethnicity Diversity Plan: How It Affects Clinical Trials

Often, far fewer minority racial and ethnic groups appear in clinical trials than in the patient population. The benefits of promoting diversity and inclusion in medical studies have been well documented, and organizations are increasingly recognizing the importance of creating an inclusive environment.

In April 2022, the Food and Drug Administration released draft guidance to help medical product creators create a race and ethnicity diversity plan “to enroll adequate numbers of participants in clinical trials from underrepresented racial and ethnic populations in the United States.” In addition to improving racial and ethnic diversity in clinical trial enrollment, the FDA also seeks to support the U.S. government’s Cancer Moonshot plan to make cancer care more equitable.

In this article, the authors discuss the benefits of diversity in clinical trials, including increased creativity and innovation, better decision-making, and improved engagement and satisfaction. They also provide practical steps that study teams can take to achieve greater inclusion.