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

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a standardized approach for collecting and reporting on race and ethnicity data in clinical trials and studies in a new draft guidance document.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 The new FDA guidance updates a 2016 draft guidance document and takes a broader approach that includes observational studies as well as interventional clinical trials.

“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diet, environmental exposure, socioeconomic status, culture), or interactions between these factors,” FDA wrote in the draft guidance. “Collecting data on race and ethnicity is critical to identifying population-specific signals.”

Collecting data

When collecting data, FDA recommends that trial and study sponsors use a two-question format that asks for information about ethnicity before asking about race.

FDA recommends that researchers collect at least two ethnicity options:

Hispanic or Latino
Not Hispanic or Latino

For race, the agency recommends at least the following choices, with the option to select one or more designations:

American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian or Other Pacific Islander
White

The use of the term “non-white” is not considered an acceptable category, according to the guidance.

In some circumstances, sponsors may want to collect more detailed ethnicity and race information, such as for trials that enroll participants outside of the US. “FDA recognizes that the recommended categories for race and ethnicity were developed in the United States and that these categories may not adequately describe racial and ethnic groups in other countries,” the agency wrote.

The draft guidance provides examples of additional ethnicity and race categories that can be added.

The agency also recommends that trial participants be able to self-report their race and ethnicity rather than have it assigned by the study team.

“While data on race and ethnicity may be available in a patient’s medical record, FDA recommends that investigators and/or other clinical study staff verify the accuracy of the information provided in the medical record with the study participant,” the agency recommended in the guidance.

Reporting data

When submitting marketing applications electronically to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), the agency recommends a tabular display of demographic data by treatment group.

Proposed product information should also include race and ethnicity information, according to the guidance. The Clinical Studies section of the product labeling should include baseline race and ethnicity data on the studied population, and the Adverse Reactions section should include baseline demographic data on the safety population.

If the safety and efficacy populations in a study are “generally the same” and are included in the Clinical Studies section, the Adverse Reaction section can cross reference the Clinical Studies section, according to the guidance.

The comment period closes on 29 April 2024. Public comments can be submitted to regulations.gov using docket number FDA-2016-D-3561.

Draft guidance

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

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