The FDA has taken a step toward improving the diversity of participants in clinical trials with the release of its 2024 draft guidance on enhancing inclusivity titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Guidance for Industry.” The FDA accepted comments on the draft until September 26th; however, the official publication date of the guidance has not been released.

The FDA aims to enhance representation in clinical trials by promoting diversity across race, ethnicity, gender, age, and other demographic factors. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved,” said FDA Commissioner Robert M. Califf, M.D.

The new guidance will support measures that enhance representation in clinical studies to create more equitable and timely access to medical advancements, improve the applicability of clinical trial results, and deepen the understanding of studies and tests.

Background

The draft guidance builds upon a multitude of past FDA publications, but importantly succeeds Congress’ Clinical Treatment Act of 2022 and the FDA’s 2020 final draft titled “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs.”

The Clinical Treatment Act of 2022 is a key legislative milestone that directly relates to the FDA’s latest draft guidance on clinical trial diversity by addressing one of the primary barriers to increasing participation in clinical trials: financial access. The act promotes “access to life-saving therapies for Medicaid enrollees by ensuring coverage of routine patient costs for items and services furnished in connection with participation in qualifying clinical trials.”

The FDA’s 2020 final draft, “Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs,” laid important groundwork emphasizing the need for sponsors to broaden eligibility criteria, reduce unnecessary exclusions, and adopt inclusive trial designs. Though the suggestions in the guidance encourage best practices, implementation has remained a challenge.

Why Clinical Trial Diversity Matters

Clinical trials are the foundation for developing new treatments, procedures, and medical devices. Minority participation in clinical trials has been insufficient and, as a result, clinical trial findings may not fully reflect the experiences of all affected individuals.

The Lung Cancer Foundation of America has researched and understands the importance of inclusivity in clinical trials stating the lack of minority participation creates a misrepresentation of communities during treatment.

Dr. Sitapriya Moorthi at the Fred Hutchinson Cancer Research Center points out that much of the clinical research regarding lung cancer focuses on “patient cohorts with a smoking history,” despite the fact that 24% of lung cancer cases in women are those who have never smoked. This narrow focus not only restricts the applicability of research findings to all patients but also hampers the development of targeted treatments for groups like non-smokers.

Key Aspects of the 2024 Draft Guidance

The 2024 guidance expands on the objectives of earlier FDA efforts while also introducing new elements aimed at enhancing regulatory practices and ensuring more comprehensive oversight.

1. The 2024 guidance requires sponsors to submit a Diversity Action Plan including specific strategies for recruiting participants from underrepresented populations to the FDA. For drugs, the Diversity Action Plan is required for Phase 3 clinical investigations or other pivotal studies. For devices, the Diversity Action Plan must be included in the Investigational Device Exemption (IDE) application for significant risk devices or in studies involving exceptions from informed consent.
2. The guide emphasizes that the content of Diversity Action Plans must include components required under sections 505(z) and 520(g)(9) of the FD&C Act. These components include the sponsor’s objectives for participant enrollment in the clinical study, categorized by race, ethnicity, sex, and age group relevant to the study populations, the sponsor’s justification for these objectives, and the sponsor’s strategy for achieving the enrollment objectives.
3. To promote transparency, FDA urges sponsors to share their Diversity Action Planstrategies with the public via their website. It is encouraged to publish specifically primary enrollment goals by race, ethnicity, sex, and age along with a summary of actions taken to meet these goals.

Regulatory Implications and Industry Impact

The guidance represents regulatory challenges and presents opportunities for sponsors and clinical researchers. Meeting new standards requires adjustments to trial designs, recruitment strategies, and data collection methods. Prioritizing inclusivity enhances the relevance and applicability of treatments, potentially supporting a smoother regulatory review.

• Trial Designs: Sponsors may need to incorporate adaptive or decentralized elements, such as virtual visits, to ensure the trial can accommodate participants with varying healthcare access or mobility limitations, broadening the scope of who can participate.
• Recruitment Strategies: Community partnerships and targeted outreach are critical for building trust with underrepresented populations, which may involve hiring diverse site staff and using materials in multiple languages to improve outreach and engagement.
• Data Collection Methods: Collecting detailed demographic data and considering participant-specific support (e.g., providing childcare) can help reduce obstacles that traditionally limit diverse participation, leading to more representative data.

The requirement for Diversity Action Plans places additional regulatory surveillance on sponsors, as the plans must not only reflect diversity of the overall population but also demonstrate that the strategies for doing so are robust and achievable. Non-compliance or failure to meet diversity targets could result in delays in trial approvals or requests for additional data by regulatory agencies, adding to development timelines.

While the regulatory changes require strategic adjustments, the ability to adapt will fulfill compliance requirements and improve clinical outcomes reducing post-market safety issues and widening access to innovative treatments.

Regulatory Implications and Industry Impact

• Conduct a Gap Analysis: To identify gaps in current enrollment practices compared to suggestions and requirements in the new guidance, a gap analysis should be conducted.Medpoint can help assess the existing processes and provide recommendations to address these gaps, including strategies for better outreach and engagement with diverse populations.
• Integrate Diversity Metrics: Ensure that the Diversity Action Plan includes measurable objectives and metrics for tracking progress. An example of a relevant metric could be the percentage of participants from underrepresented racial and ethnic groups compared to the prevalence of a specific condition in those populations. This would help ensure the trial population reflects the real-world demographics affected by a specific disease or illness being studied. Medpoint can assist in setting up systems for monitoring and reporting these metrics to ensure compliance with the guidance and to demonstrate commitment to diversity.
• Ongoing Monitoring and Evaluation: Establish procedures for continuous monitoring and evaluation of enrollment practices and the effectiveness of the Diversity Action Plan. Medpoint can support ongoing evaluation efforts, providing insights and recommendations for continuous improvement.
• Update Documentation and Procedures: Revise study protocols and other relevant documentation to reflect the new diversity requirements. An example of this may be to add inclusion criteria to study protocols such as setting quotas or establishing targeting outreach plans to actively recruit participants from specific racial, ethnic, or socioeconomic backgrounds. Medpoint can assist in updating these documents to ensure they are compliant with the new FDA guidance.

By collaborating with Medpoint, sponsors can effectively prepare for upcoming changes outlined in the new FDA guidance and enhance inclusivity and effectiveness in future clinical studies.

Reach out to Medpoint today for assistance: https://medpoint.com/contact-us/ 

For more information on the Food and Drug Administration’s Quality System Regulation’s amendments, visit the FDA website.

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Author: Ashlee Bailey, Project Coordinator and Social Media Manager

References

1. 116th Congress. "Promoting Access to Life-Saving Therapies for Medicaid Enrollees by Ensuring Coverage of Routine Patient Costs for Items and Services Furnished in Connection with Participation in Qualifying Clinical Trials." Congress.gov, 2019. https://www.congress.gov/bill/116th-congress/house-bill/913/text.
2. U.S. Food and Drug Administration (FDA). "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies." FDA.gov, 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-action-plans-improve-enrollment-participants-underrepresented-populations-clinical-studies.
3. Lung Cancer Foundation of America. "Lack of Diversity in Clinical Trials." LCF America, 2023. https://lcfamerica.org/about-lung-cancer/clinical-trials/lack-of-diversity-in-clinical-trials/.
4. U.S. Food and Drug Administration (FDA). "Guidance for Industry: Inclusion of Individuals of All Ages in Clinical Trials." FDA.gov, 2022. https://www.fda.gov/media/179593/download.