FDA guidance documents

In January 2024, I wrote about the FDA’s then-pending clinical research diversity requirements. Since that time, the regulatory landscape has shifted dramatically. This update outlines the most recent developments—including federal mandates under the Food and Drug Omnibus Reform Act (FDORA), the status of the FDA Diversity Action Plan (DAP) draft guidance, and what clinical trial sponsors should consider to prepare DAPs in compliance with evolving requirements.

Background

The FDORA of 2022,¹ enacted as part of the Consolidated Appropriations Act of 2023,² mandates that sponsors submit a Diversity Action Plan for:

• Phase 3 or pivotal studies of drugs and biologics
• Certain medical device trials that are not exempt from Investigational Device Exemption (IDE) regulations

DAPs are designed to improve trial inclusivity by outlining sponsor strategies for enrolling and retaining participants from underrepresented populations.

In June 2024, the FDA released a draft guidance detailing how sponsors should structure and submit DAPs. However, in January 2025, that draft was removed from the FDA website.

Per a court order, Health and Human Services (HHS) was required to restore this to the DAP guidance website³ on February 11, 2025. As of May 2025, the requirement for submitting DAPs remains in effect under FDORA. However, the regulatory framework may be in transition under the new administration.

FDA DAP Timeline for Implementation

The FDA was expected to issue final guidance for DAP this year, following the below anticipated timeline:

1. FDA issues draft guidance³ (already published, June 2024)
2. 60-day public comment period⁴ (ended September 26, 2024)
3. Final guidance issued within nine months after the closing of the comment period on the draft (should be due on June 26, 2025)
4. 180 days later, DAP requirements apply to new qualifying studies for which enrollment commences 180 days after publication of the final guidance

According to FDORA, the compliance deadline for mandatory submission of diversity action plans is linked directly to finalizing the FDA guidance. Leadership changes have prompted renewed discussion about finalizing the guidance, and commitments have been made at the federal level to clarify expectations. As of this writing, the final FDA guidance has not yet been issued, and the timeline for enforcement remains pending.

In January 2025, Robert F. Kennedy Jr. told U.S. senators during his confirmation hearing for the position of U.S. Department of Health and Human Services Secretary, which oversees the FDA, that he would finalize the FDA’s guidance on increasing clinical trial diversity. However, he did not commit to a specific timeline or guidance content.

Current Clinical Research Landscape

As of early 2025, over 460,000 studies are registered on ClinicalTrials.gov⁵ and about 65,000 are actively recruiting. Recruiting diverse participants has long been a challenge, but one thing is certain: the heroes of research are the participants themselves.

While there has been progress, clinical trial participation still does not proportionately reflect the racial, ethnic, and demographic diversity of the U.S. population. This mismatch becomes even more concerning when treatments are intended for global use.

Representation Gap: Why It Matters

Despite growing awareness, clinical trials continue to underrepresent key segments of the population:

• Black/African American individuals make up approximately 14% of the U.S. population but represent only approximately 5-7% of clinical trial participants.⁶
• Hispanic/Latino individuals comprise approximately 18% of the U.S. population, but less than 8% of trial participants identify as Hispanic.⁷
• Women are frequently underrepresented:
  • • Cardiovascular disease: 41.9% female participants vs. 49% disease prevalence
    • Psychiatry: 42% female participants vs. 60% disease prevalence
    • Cancer: 41% female participants vs. 51% disease prevalence.⁸
• Older adults, people with disabilities, and rural residents are also underrepresented, even when they are the primary treatment populations.⁹

These disparities can compromise the real-world relevance of clinical trial findings, impacting both drug efficacy and patient safety. A diverse study population reveals how treatments work in different groups and identifies potential differences based on factors like age, gender, race, and ethnicity.

Marginalized racial and ethnic groups, women, and other historically disenfranchised populations are substantially underrepresented in clinical trials, despite increasing concern about this issue among policymakers, patient advocates, and some industry leaders.”
— New England Journal of Medicine¹⁰

DAP Requirements at a Glance

Sponsors must include:

• Overview of the disease/condition and affected populations
• Scope of the development program
• Enrollment goals for underrepresented racial and ethnic groups
• Strategies to enroll and retain those participants and overcome enrollment barriers such as demographic-specific outreach, inclusion and exclusion practices, and diversity training for study personnel
• Updates on progress toward enrollment targets

The FDA may issue waivers in certain situations, such as during public health emergencies or when a DAP is deemed unnecessary.

Implications for Sponsors

Sponsors should not wait for final guidance to begin preparation. Now is the time to:

• Review the DAP provisions in FDORA
• Draft internal procedures for collecting and reporting diversity enrollment data
• Plan site selection and outreach strategies that support representative enrollment
• Monitor regulatory updates and archived resources (e.g., gov)

How Sponsors Can Act Now

There’s no reason to wait for final FDA guidance. Proactive preparation ensures compliance and strengthens equity.

At Imperial, we support clinical research diversity through:

• Community outreach initiatives
• Inclusive patient engagement materials
• Site educational materials
• Site and patient education and compliance videos
• Recruitment strategies designed for underserved populations

Let us help you build a trial that reflects the people you serve. Contact us for more information. This blog is part of a 2-part series. Check out: Clinical Trial Diversity Action Plans: 6 Key Components for Compliance.

Additional Resources

• Why Diverse Clinical Trial Participation Matters – This article discusses the importance of increasing diversity in clinical trials and the benefits it brings to trust, fairness, and biomedical knowledge.
• A Data Infrastructure for Clinical Trial Diversity– This article explores the need for a robust data infrastructure to support the inclusion of diverse populations in clinical trials.
• Broadening Eligibility Criteria and Diversity among Patients for Cancer Trials– This article examines how data-driven evaluation of clinical trial eligibility criteria can optimize the inclusion of historically underrepresented groups.

References

1. #2697 New FDAR white paper- The Food and Drug Omnibus Reform Act of 2022 (FDORA)_B
2. BILLS-117hr2617enr.pdf
3. U.S. Food & Drug Administration. Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (Draft Guidance, June 2024). Download Draft Guidance Here (Attachments – Center of the Page)
4. Regulations.gov – Diversity Action Plans To Improve Enrollment of Participants From Underrepresented Populations in Clinical Studies; Draft Guidance for Industry; Availability
5. Home | ClinicalTrials.gov
6. NIH/NCI – Black/African American Participation
7. PMC – Hispanic Participation Disparities
8. PubMed – Gender Representation in Trials
9. National Academies – Disabilities and Trial Access
10. NEJM – Perspective on Clinical Trial Reform