FDA, CTTI Convening Virtual Public Workshop on Enhancing Clinical Study Diversity

The U.S. Food and Drug Administration (FDA), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is convening a virtual 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 free two-day virtual public workshop will be held on November 29 and 30, 2023, from 10 a.m. – 2 p.m. EST on both days. Registration for the workshop is now open and an agenda for the workshop can be viewed here. 

We are inviting those who register to submit questions for our speakers and panelists in advance of the meeting. Please click here to submit your questions.

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

The workshop fulfills a requirement under section 3603 of the Food and Drug Omnibus Reform Act of 2022 (FDORA).