FDA issues guidance to enhance diversity in clinical trials, encourage inclusivity in medical product development

Nov. 10, 2020

The U.S. Food and Drug Administration (FDA) issued a final guidance on increasing diversity among people who enroll in clinical trials, according to a press release from the agency.

The final guidance, “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 FDA said. The guidance provides recommendations for how sponsors can increase enrollment of underrepresented populations in their clinical trials.

“We have seen these healthcare 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,” FDA Commissioner Stephen M. Hahn, MD, said.

The FDA said the 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.

In addition, the 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 also said 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, such as women, including pregnant women; racial and ethnic minorities; children and older adults. 

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