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For Immediate Release:
Statement From:

Statement Author

Leadership Role

Commissioner of Food and Drugs – Food and Drug Administration

Stephen M. Hahn
M.D.

Throughout my career as a cancer doctor and medical researcher, I have been concerned about and have sought to address issues related to health care disparities. One important step that researchers and medical product sponsors can take to confront health care disparities is to make sure that clinical trials for medical products are more inclusive of multiple populations.

We have seen these health care disparities, for example, during our fight against COVID-19, as certain segments of the population (e.g., older adults, pregnant women, children, and racial and ethnic minorities) are affected in different ways. This difference in impact illustrates why we must encourage developers of any medical product such as treatments or vaccines for COVID-19 – as well as medical products more broadly – to endeavor to include diverse populations to understand their risks or benefits across all groups.

To further promote and protect public health, it is important that people who are in clinical trials represent the populations most likely to use the potential medical product. In that spirit, today 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 (e.g., sex, race, ethnicity, age, location of residency) and non-demographic characteristics (e.g., patients with organ dysfunction, comorbid conditions, and disabilities; those at weight range extremes; and populations with diseases or conditions with low prevalence).

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

The guidance also includes other high-level considerations about 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 guidances.  

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, an agency within the U.S. Department of Health and Human Services, protects the 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. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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