FDA Seeking Comment on New Draft Guidance on Diversity Action Plans

By PSI Staff Writer

Increasing diversity within clinical studies, especially for historically underrepresented populations, is one of our industry’s most critical challenges today. The U.S. Food and Drug Administration (FDA) has released a long-anticipated draft guidance to assist sponsors in developing detailed strategies for reaching this key goal. Released on June 26, the draft guidance Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies is now open for comment for 90 days.

What is the purpose of the draft guidance?

The guidance provides clarity for sponsors, researchers, and stakeholders in developing Diversity Action Plans, underscoring the importance of their role in this vital initiative. “Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, M.D. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data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.”

The guidance also encourages sponsors to consider dimensions of diversity beyond the usual definitions, such as age, ethnicity, sex, and race. Studies should seek to enroll and retain populations that are representative of the patients who will be treated if the drug is approved.

What does the draft guidance include?

The guidance covers such topics as:

  • The format and content of Diversity Action Plans, including data-based rationale and goals for study enrollment separated by population and how the sponsor plans to meet those goals and measure progress
  • The types of medical products and clinical studies that require a Diversity Action Plan
  • Timing and process for submitting plans to the FDA
  • The agency’s criteria and process for evaluating waiver requests for required plans

Which trials does the guidance cover?

As required by recent provisions of the Federal Food, Drug and Cosmetic Act added by the Food and Drug Omnibus Reform Act (FDORA), the requirement to submit Diversity Action Plans applies to phase 3 clinical studies and, as appropriate, other pivotal clinical studies of a drug or biological product. The requirement also applies to certain device trials, including those intended to serve as the FDA’s primary basis for evaluating safety and effectiveness and benefit-risk determination. Where not required, the FDA strongly recommends that sponsors implement a diversity strategy whenever possible, including in early-phase studies.

When will the guidance be in effect?

These new requirements will apply to all relevant trials that start enrollment after 180 days from the final guidance publication date. However, sponsors should begin planning early to ensure compliance.

How can I learn more?

For more information on whether your study requires a Diversity Action Plan and what should be included, schedule a meeting with PSI. PSI specializes in pivotal Phase 2 and 3 trials and has a global regulatory team to help you ensure compliance with the FDA and other key regulatory bodies. In addition, our machine-learning-powered tool VISIONAL™ makes it easy to model the optimal scenarios for enrolling key populations by comparing hundreds of country and site combinations, their budgets, and the probability of success within just a few minutes. To learn more, contact us today.