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April 22, 2022

FDA Issues Guidance to Increase Diversity in Clinical Trials

The FDA has issued draft guidance for sponsors of medical products to increase the diversity of participants in clinical trials. In 2020, the FDA data snapshot on diversity showed that the vast majority of participants enrolling in clinical trials for medical products were White. The goal of the guidance is to increase the enrollment of participants from underrepresented ethnic and racial groups, and to enhance clinical trial diversity. This guidance is consistent with the Biden Administration’s Cancer Moonshot goals of addressing inequities in cancer care.