FDA Public Workshop on Clinical Trial Diversity

CENTER FOR DRUG EVALUATION AND RESEARCH

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The U.S. Food and Drug Administration, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a public workshop to solicit input on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups. The meeting fulfills a requirement under section 3603 of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

Please save the date for this free, two-day, virtual public workshop:

Wednesday, November 29, and Thursday, November 30, 2023

10 a.m. – 2 p.m. ET (same time on both dates)

Representatives from drug sponsors, medical device sponsors, clinical research organizations, academia, patients, and other stakeholders will share their experiences and approaches for increasing enrollment and encouraging participation of historically underrepresented populations in clinical studies.

Additional information about the public workshop along with registration details will follow in advance of the workshop.