Patient recruitment

How to improve diversity in clinical trial enrollment at your site

By TrialNotice · Updated
Coordinator in teal scrubs talking with an older man and his adult daughter in a clinic waiting room
Short answerSites improve enrollment diversity mainly by reaching patients where they already get care: community physicians, local organizations, and accessible locations, with materials and staff that fit the community. On the regulatory side, FDORA requires sponsors to submit Diversity Action Plans for certain pivotal studies, but the requirement only takes effect 180 days after FDA publishes final guidance, which had not happened as of August 2026.

Where does the federal requirement stand?

The Food and Drug Omnibus Reform Act of 2022 requires sponsors to submit Diversity Action Plans for Phase III and other pivotal studies. FDA published draft guidance in June 2024. Per FDA's report to Congress, the submission requirement applies only to studies that begin enrollment more than 180 days after final guidance is published (FDA). The final guidance will set the binding format and trigger that deadline (King & Spalding). As of August 2026, no final guidance had been published, and the draft had been removed and later restored by court order (Sakara Digital). Many sponsors still pursue diversity goals voluntarily (FDA).

Why do enrollment gaps persist?

  • Where trials are offered. Cancer trial enrollment was 21.6% at NCI designated comprehensive centers versus 4.1% in community programs (Healio), yet most patients are treated in the community (Unger et al.).
  • Who gets asked. Only 10% of people who never participated were ever asked (CISCRP).
  • Practical barriers: travel, time off work, caregiving, language.

What works at the site level?

  1. Go where patients get care. Community physicians see the patients academic centers miss.
  2. Partner locally. In one Alzheimer's study, a community outreach event recruited 69 participants while a primary care physician education effort recruited none (PubMed).
  3. Hire staff who reflect the community, including bilingual coordinators.
  4. Reduce burden: evening hours, transportation support, and reimbursement where the IRB approves.
  5. Track demographics by source so you know which channels reach whom.

Why are community physicians central?

Patients trust their own doctors, and the doctors who serve underrepresented communities are mostly in community practice, not academic centers. A referral network that includes primary care and specialty practices across your area, not only the nearest hospital, is the most direct way to widen who hears about your studies.

Get your study in front of the right local physicians

TrialNotice builds a physician referral pipeline around one active study. We identify relevant local physicians within driving distance of your site, send study aligned direct mail, follow up by email and LinkedIn, track engagement with recipient level QR codes, and route warm responses into your site team's workflow.

Talk to TrialNotice

Sources

  1. FDA, Report to Congress: Diversity Action Plans Summary, FY 2023 and FY 2024
  2. King & Spalding, "FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA"
  3. Sakara Digital, "Clinical Trial Diversity Action Plans: The Data and Systems Behind the Commitment" (status checked August 2026)
  4. Healio, "More than 20% of patients participate in cancer research" (summary of Unger et al.)
  5. Unger J.M. et al., "National Estimates of the Participation of Patients With Cancer in Clinical Research Studies," Journal of Clinical Oncology, PubMed
  6. "Comparison of recruitment efforts targeted at primary care physicians versus the community at large for participation in Alzheimer disease clinical trials," PubMed
  7. CISCRP, 2017 Perceptions and Insights Study: Decision Making Process

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