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Collection and Reporting of Race and Ethnicity Data in Clinical Trials

This guidance provides FDA expectations and recommendations for using a standardized approach for collecting and reporting race and ethnicity data in clinical trial submissions for FDA-regulated medical products (drugs, biologics, and devices) conducted in the United States and abroad. The guidance aims to ensure consistent collection of demographic subgroup data using standard terminology for race and ethnicity based on the Office of Management and Budget (OMB) Directive 15.

  1. Implement two-question format for collecting race and ethnicity data
  2. Ensure self-reporting of race/ethnicity information by trial participants
  3. Use standardized minimum categories:
    • For ethnicity: Hispanic/Latino and Not Hispanic/Latino
    • For race: American Indian/Alaska Native, Asian, Black/African American, Native Hawaiian/Pacific Islander, White
  4. Allow selection of multiple racial designations
  5. Consider using more detailed categories for international trials while maintaining traceability to minimum designations
  6. Present demographic data according to eCTD guidance and standardized categories
  7. Review data collection procedures to ensure compliance with guidance recommendations
  8. Consult with FDA review division if concerns exist about race/ethnicity categories
  9. Plan for electronic submission of marketing applications (after May 2017)
  10. Document justification for any deviation from recommended categorization approach

Key Considerations

Clinical testing

  • Use two-question format for collecting race and ethnicity data, with ethnicity question preceding race question
  • Allow self-reporting of race and ethnicity information
  • Permit designation of multiracial identity
  • When self-reporting not feasible, collect information from first-degree relative or knowledgeable source
  • Race and ethnicity should not be assigned by study team

Labelling

  • Present tabulated demographic data for all clinical trials using standardized race and ethnicity characterizations
  • Term “nonwhite” is not acceptable for use in presentation of data

Software

  • For electronic submissions, follow ICH M4E eCTD guidance for presentation of demographic data
  • Beginning May 2017, marketing applications must be submitted electronically for CDER and CBER

Other considerations

  • 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: 2023-08-10
  • Status: FINAL
  • Official FDA topics: Medical Devices, Good Clinical Practice (GCP), Drugs, Biologics, Investigational Device Exemption (IDE), Clinical - Medical
  • ReguVirta summary file ID: b602f6ce23ba132b801023aee05f6c26
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