Patients in a waiting room with healthcare professionals.

By Lya Rebelo, Commercial Enablement Manager

The US Food and Drug Administration (FDA) has made a significant stride in the fight against health disparities by issuing the draft guidance1 "Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials" in April 2022.

The purpose of this guidance was to provide recommendations to sponsors developing medical products on the approach for developing a Race and Ethnicity Diversity Plan (the "Plan") to enroll representative numbers of participants from underrepresented racial and ethnic populations in the United States, such as Black or African American, Hispanic/Latino, indigenous and Native American, Asian, Native Hawaiian and other Pacific Islanders, and other persons of color, in clinical trials.

These populations are frequently underrepresented in biomedical research despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population.

The April 2022 guidance mainly focused on race and ethnicity. However, the Food and Drug Omnibus Reform Act (FDORA), signed into law2 by President Joe Biden in December 2022, takes those plans beyond race and ethnicity to include enrollment by age group, sex, and other non-demographic characteristics.

Background

Here is a summary of the FDORA Clinical Trial Diversity and Modernization Statutory Deliverables. See Consolidated Appropriations Act, FDORA Sections 3601–3604 (December 2022) (P.L. 117–s328)

  • Draft guidance on Diversity Action Plans (no later than 12 months after enactment of FDORA)
  • Final guidance on Diversity Action Plans (no later than 9 months after closing the public comment period on the draft guidance on Diversity Action Plans)
  • Conduct one or more public workshops (no later than one year after enactment of FDORA)
  • Public Workshop Public Docket (open for 60 days after the public workshop/s)
  • Workshop Report/s (no later than 180 days from the close of the public comment period for the workshop/s)
  • Diversity Action Plans Annual Summary Report to Congress (no later than two years after enactment of FDORA and annually thereafter)
Critical aspects of FDORA relevant to clinical trial diversity include:
  • Legislative support for diversity: FDORA mandates that the FDA take steps to improve diversity in clinical trials, reflecting a legislative commitment to addressing health disparities.
  • Enhanced regulatory oversight: The act gives the FDA additional authority to enforce compliance with diversity plans and ensure that clinical trial data adequately represent the populations that will use the medical products.
  • Incentives and requirements: FDORA introduces incentives for sponsors to include diverse populations in their trials and may require sponsors to submit diversity plans as part of their regulatory submissions.
What is the current status?

Year one experience April 2022–April 2023: Voluntary Submission of Diversity Plans to Oncology Review Divisions part of Project Equity3 revealed that comprehensive strategy is often missing. To learn more, read this Pink Sheet article.

On Nov. 29–30, 2023, the FDA provided a two-day workshop fulfilling a requirement under Section 3603 of the Food and Drug Omnibus Reform Act of 2022 (FDORA). See the key takeaways.

In January 2024, the FDA released an updated guidance4 on the collection of race and ethnicity data in clinical trials. This update reinforces the importance of accurately capturing demographic data to ensure the inclusivity and representativeness of clinical trial participants. The updated guidance provides detailed instructions on data collection methodologies, standardizes race and ethnicity categories, and emphasizes the critical role of this data in analyzing the safety and efficacy of medical products across diverse populations.

Recently, in June this year, the FDA released all the resources5 presented during the workshop from November last year, fulfilling another FDORA requirement.

According to the FDORA requirements, the updated FDA guidance was expected on December 29, 2023 and was finally released6 on June 26, 2024. This draft guidance describes the format and content of Diversity Action Plans, the medical products and clinical studies for which a Diversity Action Plan is required, and the timing and process for submitting Diversity Action Plans to the FDA. The draft guidance also outlines the criteria and process the agency will use to evaluate a sponsor’s request not to submit a required Diversity Action Plan, also known as a waiver.

What are sponsors and CROs expecting?

Timelines & deadlines:

  • Comments on the draft guidance released on June 26, 2024, should be submitted within 90 days after publication in the Federal Register to Regulations.gov.
  • The FDA must issue final guidance within nine months after the deadline to submit comments is closed.
  • The requirement for diversity action plans applies to clinical trials whose enrollment begins 180 days after the final guidance is published.

Sponsors are making efforts to meet the regulatory requirements that apply to Phase 3 clinical studies or other pivotal clinical studies of drugs, biological products, and devices, for which enrollment commences 180 days after publication of final guidance on Diversity Action Plans.

Related resources

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FDA's Push for Diversity: Addressing Data Challenges in Clinical Trials Via Race/Ethnicity Guidance

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Top 5 Insights from FDA Public Workshop to Enhance Clinical Trial Diversity

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