FDA Proposes Guidance for Increasing Diversity in Clinical Trials

The US Food and Drug Administration (FDA) recently announced new draft guidance that aims to increase the number of participants from underrepresented populations in clinical trials in the US and globally by requiring medical product sponsors to submit strategies, known as diversity action plans. Age, ethnicity, sex, and race are all factors that can contribute to clinical trial diversity, but sponsors should also consider types of diversity beyond those, such as geographic location, sexual orientation, or socioeconomic status, the FDA wrote.