30 Jan Clinical trials: FDA proposes new standards for collecting race, ethnicity data

By Mary Ellen Schneider, Regulatory News

The US Food and Drug Administration (FDA) is outlining a standardized approach for collecting and reporting on race and ethnicity data in clinical trials and studies in a new draft guidance document.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 FDA’s recommendations are based on a policy directive from the US Office of Management and Budget (which is currently under revision), guidance from the US Health and Human Services department, and the agency’s own action plan to enhance collection and availability of demographic subgroup data. The new FDA guidance updates a 2016 draft guidance document and takes a broader approach that includes observational studies as well as interventional clinical trials. Read more…