Pending FDA Clinical Trial Diversity Requirements

by Vaughn X. Anthony

Diversity in clinical trials is becoming mandatory, which can make drugs and devices more widely beneficial. New FDA regulations are coming; read on for our understanding of what to expect.

Right now, almost a half million studies are registered on, and about 65,000 are currently recruiting. We often say participants are the heroes of research, and sponsors apply great resources to recruit them.

We all know the statistics regarding minority representation in clinical trials. Too often, the patients who will ultimately use the drugs and devices under study are not adequately represented in trials. The following statistics show demographics for participation in clinical trials compared to the actual population of the U.S.

Overall, the inclusion of diverse race/ethnic populations in clinical trials has improved over the years, but the numbers above show that minority study populations do not yet match their percentages of the U.S. population. If the drug or device is to be used worldwide, there is even more disparity in representation.

Sponsors and the FDA have recognized the importance of including racial and ethnic minority groups, as well as other populations experiencing health disparities. Efforts seem to be progressing toward including these populations and may involve common strategies such as using advocacy groups to promote trial awareness and making recruitment materials more inclusive.

FDA guidance documents address diversity, often stressing the importance of selecting sites located in areas where larger populations of diverse people reside and receive their health care.

Around the corner: the U.S. will require a clinical trial diversity action plan

Until recently, diversity goals have been addressed under a draft guidance from the FDA. A government funding bill called the Consolidated Appropriations Act 2023 (H.R. 2617), signed into law by President Biden is bringing diversity to the next level.

Inside the legislation is the Food and Drug Omnibus Reform Act of 2022, called FDORA, which specifies the goals of promoting diversity, decentralization, and the modernization of clinical trials. In the legislation, sponsors of some clinical trials will be required to submit a diversity action plan (DAP) to the Secretary of the Department of Health and Human Services. If you’d like a look at the long legal document, check it out here; for the diversity action plan, start with Subtitle F, which you will find deep down on page 1,402.

What will sponsors be expected to provide in the DAP?

  • Overview of what is known about the disease/condition and the population who has it
  • Scope of the medical product development program
  • Goals for enrollment of underrepresented racial and ethnic participants
  • A specific plan of action to enroll and retain diverse study participants and overcome barriers to enrollment
  • Status of meeting enrollment goals

The DAP requirement applies to Phase 3 Clinical Studies or other pivotal clinical studies of drugs, biological products, and devices. Waivers will be available if the FDA determines a DAP is not necessary or practical, or if the waiver is needed to protect public health during a public health emergency.

When does all this happen?

We are still waiting for the FDA’s draft guidance document encompassing the new reform act. Some of the expected items for inclusion are:

  • Race and ethnicity
  • Sex
  • Gender identity
  • Age
  • Socioeconomic status
  • Disability
  • Pregnancy and lactation status
  • Comorbidity

Once the draft guidance is issued, a 60-day public comment period opens.

Final guidance will be issued no later than 9 months after the public comment period ends.

Once final guidance is issued, qualifying studies that begin 180 days and later will require clinical trial diversity action plans.

We will be following developments regarding this important legislation and will keep you posted with updates.

Additional reading:

FDA website promoting diversity to potential participants

FDA brochure with basic trial information

Project Equity information

FDA Clinical Trial Diversity Slide Deck

Final thoughts

Enrolling diverse populations expands clinical information, reduces biases, promotes social justice, and ultimately, has the potential to make our drugs and devices more widely beneficial. There is no reason to wait for legislation; Imperial’s subject matter experts are ready to help you attract more diverse participants for your trial, and we are eager to work with you to attain this important goal.

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