The US Food and Drug Administration (FDA) has released a draft guidance detailing the requirements for diversity action plans for certain clinical trials.

Dubbed ‘Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies’, the guidance aims to increase the representation of historically underrepresented populations in clinical research.

This approach is aimed at enhancing the quality and applicability of data across diverse patient groups.

The guidance also outlines the necessary steps for medical product sponsors to submit Diversity Action Plans, which are now required for specific trials.

Furthermore, the FDA’s draft guidance stipulates that Diversity Action Plans should detail sponsors’ strategies for enrolling a diverse range of participants by age, ethnicity, sex and race.

These plans are crucial for ensuring that clinical study results apply to the broader patient population and provide valuable insights into the safety and effectiveness of medical products.

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The guidance further explains the types of medical products and studies that necessitate a Diversity Action Plan and the timing and process for FDA submission.

It also details the criteria for evaluating waiver requests from sponsors who seek exemption from submitting a plan.

The mandate for Diversity Action Plans originates from the provisions of the Federal Food, Drug and Cosmetic Act added by the Food and Drug Omnibus Reform Act (FDORA).

These plans are particularly relevant for Phase III or other clinical studies of assets, biological products, and certain device studies that form the basis of the FDA’s safety, effectiveness, and benefit-risk assessments.

Trials that begin enrolling subjects 180 days following the publication of the final guidance will be subject to the requirement of submitting a Diversity Action Plan.

FDA commissioner Robert Califf said: “Participants in clinical trials should be representative of the patients who will use the medical products.

“The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data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.”