Stephen M. Hahn, MD, Commissioner at the U.S. Food and Drug Administration (FDA), recently issued a statement regarding an important step that researchers and medical product sponsors can take to make sure 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 (eg, older adults, pregnant women, children, and racial and ethnic minorities) are affected in different ways,” Dr. Hahn said. “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.”
Stephen M. Hahn, MD
Dr. Hahn announced that the FDA has issued a final guidance with the agency’s recommendations on designing and executing clinical trials of drugs and biologics that include people with different demographic characteristics (eg, sex, race, ethnicity, age, location of residency) and nondemographic characteristics (eg, patients with organ dysfunction, comorbid conditions, and disabilities; those at weight-range extremes; and populations with diseases or conditions with la ow prevalence).
Expanding Participation in Clinical Trials
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 methodologic approaches. It offers recommendations on how product sponsors can improve clinical trial diversity by accounting for logistic and other 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 can replace site visits and provide investigators with real-time data.
Additionally, 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. It 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—such as women, pregnant women, racial and ethnic minorities, children, and older adults—and provides references to more specific guidances.