Clinical Research: Phase 1 - Phase 4

FDA’s Push for DEI in Clinical Trials: What Sponsors Need to Know in 2024

In the ever-evolving field of global clinical research, the integration of diversity, equity, and inclusion (DEI) has become a pivotal focus, especially considering recent FDA initiatives and legislative changes. The U.S. Food and Drug Administration’s (FDA) ongoing efforts, coupled with the enforcement of the DEPICT Act and impending final regulatory guidance, highlight the urgency and importance of incorporating DEI principles in clinical trials for regulatory compliance and to enhance the quality and relevance of clinical research. In part one of this blog series, we outline key aspects of the FDA’s draft guidance and other legal considerations for clinical trial sponsors to incorporate into their clinical development plans. Stay tuned for parts two and three where we outline strategies for implementing DEI in clinical trial design and recruitment, and provide considerations for regional differences.

A Roadmap for Closing the Gap on DEI Requirements in Clinical Research

Continuing a trend to promote diversity in clinical trials, the FDA published draft guidance documents titled: Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry and Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products.

Taken together, these documents propose regulatory strategies that clinical trial sponsors can utilize to enhance data for populations underrepresented in clinical research. Importantly, the draft FDA guidance requires that clinical trial sponsors present data on the safety and effectiveness of drugs and biologics in terms of gender, age, and racial subgroups.

It also suggests that the FDA will use its authority to ensure that relevant subpopulation data is collected. Failure to include adequate representation from diverse populations in ongoing or future clinical trials may delay product approval or cause a new drug or device to be rejected.

Key aspects of the draft guidance include:

  • FDA will evaluate the race and ethnicity diversity plan as an important part of the sponsor’s development program
  • For drugs, sponsors should submit the plan to the investigational new drug application as soon as practicable during drug development but no later than when a sponsor is seeking feedback regarding the applicable pivotal trial(s) for the drug (i.e., end of Phase 2 meeting)
  • Sponsors should request FDA feedback on the plan
  • For medical devices, sponsors should submit their plan as part of the investigational plan included in the investigational device exemption (IDE) application
  • Sponsors should include the plan in the marketing application for the medical product as well as a description of the successes and challenges in implementing it

Other Legal Considerations

The Diverse and Equitable Participation in Clinical Trials (DEPICT) Act passed in 2022 requires applications for an investigational use exemption of a new drug or medical device to include information about the demographic diversity of the clinical trial population and address related issues. And the Food and Drug Omnibus Reform Act of 2022 (FDORA) required sponsors to submit a “diversity action plan” for all Phase 3 clinical trials conducted for drugs and biologics, and the same for all devices and diagnostics that use the 510(k), premarket approval (PMA), de novo, and IDE pathways, with some exceptions.

These laws highlight the need for sponsors to prepare diversity plans that comply with both FDA guidance and other legal requirements.

Embracing a Diverse Future

As 2024 begins, anticipation mounts regarding the final FDA guidance, likely to build upon the draft guidance released in April 2022. Michelle Tarver, deputy center director and chief transformation officer at FDA’s Center for Devices and Radiological Health, told attendees at the October 2023 MedTech conference that the FDA’s draft guidance on DEI is expected to be finalized imminently.

As professionals in clinical development and regulatory affairs, embracing and implementing DEI in clinical trials is pivotal. This commitment extends beyond mere compliance; it contributes significantly to the advancement of science and benefits society by ensuring that clinical research is inclusive and reflective of the diverse populations it aims to serve. A commitment to DEI is imperative to advancing healthcare for all.

Premier Research stands ready to offer expertise in this area. Our team of seasoned professionals is equipped to provide comprehensive consulting services, ensuring your clinical trials not only meet regulatory requirements but also embody the true spirit of diversity, equity, and inclusion.

To learn more about facilitating and ensuring diversity compliance in your clinical study, contact us.