FDA Public Workshop on Clinical Trial Diversity

FDA is holding a two-day virtual public workshop to enhance clinical study diversity. This workshop is being held on November 29 and 30, 2023 10 a.m. – 2 p.m. ET

FDA is seeking input on increasing the enrollment of historically underrepresented populations in clinical studies and ways to encourage clinical study participation that reflect the prevalence of the disease or condition among demographic subgroups.

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.

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Save the Date Two-Day Virtual Public Workshop to Enhance Clinical Study Diversity November 29 and 30, 2023 10 a.m. – 2 p.m. ET

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.

Increasing diversity of study participants in clinical trials and expanding the pool of participants is very important to provide useful information on safety and efficacy of products in diverse people.