Collection of Race and Ethnicity Data in Clinical Studies – Standardizing the Sociocultural Construct of Our Society

In January 2024, the FDA released a draft guidance update on the Collection of Race and Ethnicity Data in Clinical Trials, originally issued in October 2016.

For industry and the FDA, this guidance is important as it intends to standardize the approach for collecting and reporting race and ethnicity data in submissions–including information collected and reported from clinical studies for FDA-regulated products. The FDA is recommending the use of the Office of Management and Budget (OMB) race and ethnicity categories for investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs) and medical device applications.

Additionally, the FDA recommends that OMB-standardized race and ethnicity information are included in proposed product labeling. Demographic information, including racial and ethnic characteristics, of the studied population should be included in the CLINICAL STUDIES section of drug and biological product labeling. The baseline demographics of the safety population should be included in the ADVERSE REACTIONS section.

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Although not legally enforceable at this time, Sponsors should plan for implementation of a Diversity Action Plan[1] outlining:

1. The Sponsor’s goal for enrollment
2. The rationale for the goals
3. The plan to meet these goals

Implementation of this plan will become a requirement for medical products starting enrollment 180 days after the final guidance on diversity action plans is published[2]. The goal is for Sponsors of investigational new drugs and investigational devices to plan and implement how they will enroll participants who will reflect the population that will use the medical product, if approved[3].

Collecting Race and Ethnicity Data in Clinical Studies

It’s important to note that the OMB categories “are social-political constructs and should not be interpreted as being scientific or anthropological in nature.”

Trial participants should self-report race and ethnicity information, as well as have the ability to select more than one option to designate a multiracial identity. If the information is available in their medical record, the FDA recommends confirming the accuracy of the data with the participant.

For collection of race and ethnicity data in clinical trials and clinical studies, the FDA has the following minimum recommendation:

• Two-question format for requesting race and ethnicity information, with the ethnicity question preceding the question about race. Example:
  • Question 1: Are you Hispanic or Latino?
  • Question 2: What is your race? Select one or more.
• Minimum Ethnicity Standard
  • Hispanic or Latino
  • Not Hispanic or Latino
• Minimum Race Standard
  • American Indian or Alaskan Native
  • Asian
  • Black or African American
  • Native Hawaiian or Other Pacific Islander
  • White

For extended OMB standards, the following categories are recommended:

• Ethnicity OMB Standard
  • Are you Hispanic or Latino? (Select one or more)
    • No, not Hispanic or Latino
    • Yes, Mexican, Mexican American, Chicano
    • Yes, Puerto Rican
    • Yes, Other Hispanic or Latino
  • Race OMB Standard
    • White
    • Black or African American
    • American Indian or Alaskan Native
    • Asian Indian
    • Chinese
    • Filipino
    • Japanese
    • Korean
    • Vietnamese
    • Other Asian
    • Native Hawaiian
    • Guamanian or Chamorro
    • Samoan
    • Other Pacific Islander

Reporting Race and Ethnicity Data in Clinical Studies

Looking at this from a global perspective, the FDA recognizes that the recommended categories for race and ethnicity may not adequately describe race and ethnicity in other countries, and more-detailed categories by geographic region may offer a better way to characterize the study population. Additionally, the term nonwhite is not acceptable for use in the presentation data.

For reporting of ethnicity and race in submissions and in product labeling, “Sponsors should report the number of respondents in each racial category who self-reported as Hispanic or Latino. When aggregate data are presented, data producers should provide the number of respondents who marked (or selected) only one category, separately for each of the five racial categories. In addition to these numbers, Sponsors are encouraged to provide the detailed distributions, including all possible combinations of responses to the race question. If data on multiple responses are condensed, at a minimum the total number of respondents reporting “more than one race” should be included.

Using the standard terminology for race and ethnicity helps ensure consistent data collection and reporting in submissions to the FDA.

[1] “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability”, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations

[2] See Food and Drug Omnibus Reform Act of 2022 (FDORA) available at https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf.

[3] See also the guidance for industry Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs (November 2020).