The report of the two-day virtual public workshop to enhance clinical study diversity, convened by the U.S. Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI), is now available. The workshop was held on November 29 and 30, 2023 with more than 2,600 global attendees. 

The workshop solicited input on strategies and considerations for increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of diseases or conditions among demographic subgroups. Speakers and panelists included representatives from the FDA and other federal agencies, academia, medical device and pharmaceutical sponsors, patients and patient advocacy groups, and research study teams. 

The workshop fulfilled a requirement under section 3603 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). View the recording and slide deck to learn more.