U.S. FDA Offers Guidance to Enhance Diversity in Clinical Trials

The U.S Food and Drug Administration issued final guidance with the agency’s recommendations on designing and executing clinical trials of drugs and biologics that include people with different demographic characteristics and non-demographic characteristics.

The final guidance issued on November 9, 2020, “Enhancing the Diversity of Clinical Trial Populations--Eligibility Criteria, Enrollment Practices, and Trial Designs,” which was first issued as a draft in 2019, offers the FDA’s current thinking on steps to broaden eligibility criteria in clinical trials through inclusive trial practices, trial designs, and methodological approaches.

FDA Commissioner Stephen M. Hahn M.D. stated in a related press statement, ‘The guidance aims to provide recommendations for how sponsors can increase enrollment of underrepresented populations in their clinical trials.’

‘This guidance offers recommendations on how product sponsors can improve clinical trial diversity by accounting for logistical and other participant-related factors that could limit participation. 

For example, clinical trials requiring frequent visits to specific sites may place an added burden on participants. Sponsors are encouraged to think about reducing visit frequency, when appropriate, in addition to considering whether flexibility in visit windows is possible and whether electronic communications, such as phone, email, social media platforms, or other digital health technology tools can replace site visits and provide investigators with real-time data. 

Additionally, this new guidance provides recommendations on broadening clinical trial eligibility criteria for clinical trials of investigational drugs intended to treat rare diseases and recommendations on improving enrollment and retention of participants with rare diseases. 

The FDA guidance notes that sponsors should consider early engagement with patient advocacy groups and patients to elicit suggestions for designing trials that participants would be willing to enroll in and support. 

Also, the guidance includes other high-level considerations about the inclusion of other important groups, including but not limited to: women, including pregnant women, racial and ethnic minorities, children, and older adults, and provides references to more specific guidance.  

Clinical trials, and the people who volunteer to participate in them, are essential to help develop safe and effective medical products to fight diseases and illnesses. 

The FDA remains committed to increasing enrollment of diverse populations in medical product development and will continue to engage with federal partners, medical product manufacturers, medical professionals, and health advocates to encourage this important goal. 

The FDA is an agency within the U.S. Department of Health and Human Services that protect public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

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