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Collection and Reporting of Race and Ethnicity Data in Clinical Trials

This guidance provides FDA expectations and recommendations for collecting and reporting race and ethnicity data in clinical trials for FDA-regulated medical products (drugs, biologics, and devices) conducted both in the United States and abroad. It aims to ensure consistent collection of demographic subgroup data using standardized categories based on OMB Directive 15.

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By ReguVirta
3 min read

What You Need to Know? 👇

FDA recommends using OMB Directive 15 categories: Hispanic/Latino or Not Hispanic/Latino for ethnicity, and five racial categories (American Indian/Alaska Native, Asian, Black/African American, Native Hawaiian/Other Pacific Islander, White) with self-reporting using a two-question format.

How should sponsors collect race and ethnicity data in multi-regional clinical trials?

Sponsors should use the standardized OMB categories as the minimum standard but may use more detailed geographic subcategories when appropriate. All detailed categories must be traceable back to the five minimum racial designations and two ethnicity designations.

What are the regulatory requirements for demographic data in drug applications?

IND holders must tabulate participants by age, race, and sex in annual reports. NDA sponsors must include safety and effectiveness summaries by demographic subgroups including racial subgroups. FDA strongly recommends collecting ethnicity data consistent with OMB standards.

Why is collecting race and ethnicity data important for medical device approval?

Race and ethnicity data helps identify population-specific safety and efficacy signals. Studies show differences in medical product responses across racial/ethnic groups due to genetic, metabolic, and other factors that can affect device performance and patient outcomes.

Can study teams assign race and ethnicity if participants cannot self-report?

No, study teams should not assign race and ethnicity. When self-reporting isn’t feasible due to participant inability to respond, information should be requested from a first-degree relative or other knowledgeable source rather than assigned by investigators.

What submission format does FDA require for demographic data in applications?

Beginning May 2017, CDER and CBER require electronic submissions using eCTD format. Demographic data should follow ICH M4E eCTD guidance with tabular displays by treatment group, using the detailed race/ethnicity categories described in FDA guidance.

What You Need to Do 👇

  1. Implement two-question format for collecting race and ethnicity data
  2. Ensure self-reporting of race/ethnicity by trial participants
  3. Use minimum standard categories for both race and ethnicity as defined in guidance
  4. Consider using more detailed geographic categories when appropriate while maintaining traceability to standard categories
  5. Prepare for electronic submission of demographic data following eCTD specifications
  6. Review and update data collection forms and processes to comply with guidance requirements
  7. Train study teams on proper collection and reporting of race/ethnicity data
  8. Establish process to validate collected demographic data meets requirements
  9. Consider discussing race/ethnicity categorization with FDA review division when concerns exist
  10. Ensure proper tabulation and presentation of demographic data in regulatory submissions

Key Considerations

Clinical testing

  • Trial participants should self-report race and ethnicity information
  • Use two-question format with ethnicity question preceding race question
  • When self-reporting is not feasible, information should be requested from first-degree relative or knowledgeable source
  • Race and ethnicity should not be assigned by study team

Labelling

  • The term “nonwhite” is not acceptable for use in Federal Government data presentation
  • Detailed distributions of multiple responses to race questions should be provided
  • At minimum, total number of respondents reporting “more than one race” must be available

Other considerations

  • For ethnicity, minimum choices must include: Hispanic/Latino and Not Hispanic/Latino
  • For race, minimum choices must include: American Indian/Alaska Native, Asian, Black/African American, Native Hawaiian/Other Pacific Islander, White
  • More detailed categories by geographic region can be used when appropriate but must be traceable to the minimum designations
  • For studies outside US, categories may need adaptation while maintaining traceability to minimum designations
  • Data should be submitted in electronic format following eCTD specifications starting May 2017

Relevant Guidances đź”—

Related references and norms đź“‚

  • ICH E5: Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data
  • ICH M4E: The CTD - Efficacy

Original guidance

  • Collection and Reporting of Race and Ethnicity Data in Clinical Trials
  • HTML / PDF
  • Issue date: 2016-10-26
  • Last changed date: 2025-02-03
  • Status: FINAL
  • Official FDA topics: Investigational Device Exemption (IDE), Medical Devices, Biologics, Drugs, Clinical - Medical
  • ReguVirta ID: b602f6ce23ba132b801023aee05f6c26
FDA guidance, Final
Investigational Device Exemption (IDE) Medical Devices Biologics Drugs Clinical - Medical
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