FDA issues revised draft on race and ethnicity data in clinical studies

The US Food and Drug Administration (FDA) has outlined a standardized approach for collecting and reporting on race and ethnicity data in clinical trials and studies in a new draft guidance document. “Using standardized terminology for race and ethnicity helps ensure that data are collected and reporting consistently in submission to FDA,” the agency wrote in the Federal Register on 30 January 2024.

The new FDA draft updates a 2016 draft guidance document and takes a broader approach that includes observational studies as well as interventional clinical trials. “Although uncommon, differences in response to medical products have been observed in racially and ethnically distinct populations in the United States. In some cases, differences in the pharmacokinetics, efficacy, or safety of medical products that lead to these different responses may be attributable to intrinsic factors (e.g., genetics, metabolism, elimination, skin pigmentation), extrinsic factors (e.g., diet, environmental exposure, socioeconomic status, culture), or interactions between these factors,” FDA comments in the draft guidance, continuing “Collecting data on race and ethnicity is critical to identifying population-specific signals.”

Comments are requested until 29 April 2024 by submitting them to regulations.gov using docket number FDA-2016-D-3561.