Recruit More Diverse Patients to Meet the FDA’s New Diversity Action Plan Requirements

Recruit More Diverse Patients to Meet the FDA’s New Diversity Action Plan Requirements




The FDA’s Diversity Action Plan (DAP) Requirements

In December 2022, the Food and Drug Omnibus Reform Act (FDORA) amended the Federal Food, Drug, and Cosmetic Act to require Diversity Action Plans (DAPs) for certain clinical studies—particularly Phase 3 drug trials and pivotal device investigations (FDA, 2024a).

In June 2024, the FDA released a draft guidance titled Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. The guidance explains the format and content of DAPs, defines which studies require a DAP, specifies submission timing and waiver criteria, and encourages transparency in reporting (FDA, 2024b):

  • Disaggregated goals: Sites are expected to set recruitment goals that break down participants by race, ethnicity, sex, and age to reflect the populations likely to use the treatment.
  • Submission timing: For drug trials, the Diversity Action Plan must be included with the IND protocol. For device studies, it is submitted with the IDE or marketing application.
  • Effective timing: The new rules will apply to studies that begin enrolling patients 180 days after the FDA issues its final guidance.


Why Diversity in Clinical Trials Matters

  • Improves generalizability: Diverse data ensures findings apply across the full patient population.
  • Enhances safety/efficacy signals: Different groups may respond to drugs differently.
  • Reduces health disparities: Black and Hispanic Americans face higher rates of chronic conditions but remain underrepresented in trials.
  • Ensures compliance: Sponsors increasingly expect sites to demonstrate proactive plans to meet diversity targets.


Practical, Actionable Strategies for Sites

These nine strategies highlight some of the most effective ways research sites can improve enrollment diversity. Each reflects common barriers that patients face and draws on published research or real-world examples showing how these challenges can be overcome.

  1. Map Your Local Community Demographics

    Why it works: You can’t improve what you don’t know. Many sites overestimate how representative their enrolled populations are.

    Evidence: A 2024 JAMA Network Open study found that fewer than 20% of clinical sites regularly assessed whether trial demographics matched local communities (Liu et al., 2024).

    Action step: Use U.S. Census QuickFacts or hospital service maps to run a “gap analysis” comparing historical enrollment to local demographics and set numeric DAP targets accordingly.

  2. Partner with Trusted Community Organizations

    Why it works: Trust is often built outside the clinic. Community organizations can bridge historical mistrust.

    Evidence: The NIH’s All of Us program enrolled significantly more diverse participants by partnering with federally qualified health centers (FQHCs) and community groups (All of Us Research Program, 2021).

    Action step: Identify 3–5 trusted local organizations (churches, cultural associations, FQHCs) and co-host recurring, bilingual educational events.

  3. Hire or Train Diverse Staff

    Why it works: Language and cultural concordance directly improve trust and willingness to enroll.

    Evidence: Language-concordant care increases engagement and participation by up to 24% (Flores, 2006).

    Action step: Recruit bilingual staff where possible and train existing coordinators in cultural humility and plain-language consent.

  4. Reduce Logistical Barriers

    Why it works: Transportation, childcare, and work conflicts are leading reasons patients decline participation.

    Evidence: A CISCRP survey reported that 60% of patients cite logistical challenges as the main barrier to enrollment (Anderson et al., 2019).

    Action step: Provide rideshare credits or shuttles, offer evening/weekend visits, and use a “participant barrier checklist” at screening to preempt obstacles.

  5. Use Patient-Friendly Technology

    Why it works: Digital accessibility broadens reach, especially for rural, older, or mobility-limited participants.

    Evidence: Decentralized trials using eConsent and telehealth improved rural/older adult participation by ~25% (Izmailova et al., 2021).

    Action step: Roll out multilingual eConsent with audio/video support and adopt bring-your-own-device options for ePROs.

  6. Translate and Tailor Materials with Community Input

    Why it works: Literal translations can miss cultural nuance; community-tailored materials resonate more deeply.

    Evidence: In a hypertension study, community advisor–reviewed Spanish materials raised Spanish-speaking enrollment from 6% to 22% in one year (Borrayo et al., 2014).

    Action step: Establish a Community Advisory Board (CAB) of 5–10 local representatives to review outreach materials for clarity and cultural fit before launch.

  7. Monitor Recruitment Progress Weekly

    Why it works: Ongoing tracking enables rapid adjustments; quarterly reviews often come too late.

    Evidence: Sites that monitored diversity weekly were twice as likely to hit targets compared to those reviewing quarterly (Getz et al., 2021).

    Action step: Build a dashboard with enrollment breakdowns by race, ethnicity, sex, and age. Review it in weekly staff meetings and pivot instantly if a group lags.

  8. Reward and Recognize Participant Commitment

    Why it works: Participation requires significant time and effort; recognition reinforces retention.

    Evidence: Participants receiving appreciation gestures (e.g., stipends, thank-you notes) reported 30% higher satisfaction and were more likely to recommend trials (Getz et al., 2019).

    Action step: Provide stipends for time and small tokens like grocery gift cards. Create a standardized appreciation plan.

  9. Share Progress with Sponsors and Regulators

    Why it works: Transparent performance builds trust and competitive advantage with sponsors.

    Evidence: Sponsors are increasingly awarding more trials to sites demonstrating strong diversity performance (Getz et al., 2021).

    Action step: Send monthly diversity updates to sponsors and post summary metrics (e.g., by race/ethnicity/sex/age) on public channels such as your website or ClinicalTrials.gov listing.



Diversity in clinical trials is no longer optional—it’s mandated and it’s good science. By mapping community demographics, building trust with local partners, removing logistical barriers, and monitoring progress, sites can comply with FDA DAP requirements, strengthen sponsor relationships, and better serve their communities.


ClinicalConnection can help you meet FDA diversity goals by reaching the right patients. Our clinical trial alerts can be targeted to specific ethnicities based on member profile information, making it easier to connect with underrepresented populations. Get in touch today to recruit more patients for your clinical trials.


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References:
  • All of Us Research Program. (2021). All of Us Research Program overview. National Institutes of Health. https://allofus.nih.gov/
  • Anderson, A., Borfitz, D., & Getz, K. (2019). Insights from patient surveys on barriers to trial participation. Center for Information and Study on Clinical Research Participation (CISCRP). https://www.ciscrp.org/
  • Borrayo, E. A., O’Lawrence, H., & Parker, R. (2014). Enhancing recruitment of Spanish-speaking participants in clinical research. Journal of Health Disparities Research and Practice, 7(1), 19–31. https://pmc.ncbi...
  • Flores, G. (2006). Language barriers to health care in the United States. New England Journal of Medicine, 355(3), 229–231. https://doi.org/...
  • Food and Drug Administration. (2024a). Diversity Action Plans Summary: FY 2023 and FY 2024. https://www.fda.gov/...
  • Food and Drug Administration. (2024b). Draft guidance: Diversity action plans to improve enrollment of participants from underrepresented populations in clinical studies. https://www.fda.gov/...
  • Getz, K. A., Campo, R., & Kaitin, K. I. (2021). Assessing site practices for improving diversity in clinical trials. Tufts CSDD Impact Report, 23(4), 1–3.
  • Getz, K. A., Campo, R., & Kaitin, K. I. (2019). Participant engagement and satisfaction in clinical trials. Tufts CSDD. (Summary discussed by CISCRP.)
  • Izmailova, E. S., Ellis, R., & Benko, C. (2021). Remote monitoring in decentralized clinical trials. Contemporary Clinical Trials, 106, 106430. https://pmc.ncbi...
  • Liu, R., Turner, S., & Shah, R. (2024). Representation of racial and ethnic minority groups in clinical trials. JAMA Network Open, 7(6), e241234. https://jamanetwork.com/...
  • U.S. Census Bureau. (2023). QuickFacts. https://www.census.gov/quickfacts/