Diversity in Clinical Trials: Enrollment Goals and Action Plans for Underrepresented Racial, Ethnic, Sex and Age Groups (DRAFT)

This is a draft guidance. Not for implementation.

Recommended Actions

1. Develop comprehensive diversity strategy early in clinical development program
2. Engage with FDA early regarding Diversity Action Plan approach
3. Establish enrollment goals based on disease prevalence/incidence data
4. Create detailed plan for meeting enrollment goals including:
   • Site selection strategy
   • Community engagement approach
   • Cultural competency training
   • Participant burden reduction measures
5. Implement monitoring system to track progress toward enrollment goals
6. Submit required plans and updates according to specified timelines
7. Include Diversity Action Plan assessments in marketing submissions
8. Consider public posting of key plan information
9. Document rationale thoroughly if requesting any waivers
10. Maintain ongoing evaluation of enrollment strategies and adjust as needed

Key Considerations

Clinical testing

• Required for phase 3 or pivotal drug studies and certain device studies
• Must specify enrollment goals disaggregated by race, ethnicity, sex, and age group
• Goals should reflect disease prevalence/incidence in intended use population
• Must include rationale for enrollment goals and plan to meet them
• Progress updates required in annual reports

Labelling

• Marketing submissions should include overview of Diversity Action Plan and assessment of whether goals were met
• Public posting of key information from plans encouraged using consumer-friendly language

Safety

• Must consider potential differential safety effects across populations
• Should evaluate genetic variations that may impact safety

Other considerations

• Early engagement with FDA recommended
• Waivers possible but granted rarely
• Plans should be concise (≤10 pages excluding references)
• Must include enrollment/retention strategies
• Should consider geographic location and socioeconomic factors
• Cultural competency training recommended
• Reducing participant burden encouraged

  Relevant Guidances

• Collection and Reporting of Race and Ethnicity Data in Clinical Trials
• Evaluation of Sex and Gender Differences in Medical Device Clinical Studies (Draft)
• Sex-Specific Considerations in Medical Device Clinical Studies: Patient Enrollment, Data Analysis and Reporting

Related references and norms

• 21 CFR 312.21: Phase 3 studies definition
• 21 CFR 312.33: IND annual reporting requirements
• 21 CFR 314.50: NDA content and format
• 21 CFR 812.3(m): Significant risk device definition
• 21 CFR 812.20: IDE application requirements
• 21 CFR 812.150: IDE reporting requirements

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Original guidance

• Diversity in Clinical Trials: Enrollment Goals and Action Plans for Underrepresented Racial, Ethnic, Sex and Age Groups
• HTML / PDF
• Issue date: 2024-06-26
• Last changed date: 2024-07-03
• Status: DRAFT
• Official FDA topics: Medical Devices, Pediatric Product Development, Drugs, Biologics
• ReguVirta summary file ID: 445b09b919c8a2417e10334ee5a7cf1a