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Clinical Insider
Clinical Insider

US FDA advises on diversity plan requirements, timings, and process

Posted by on 01 July 2024
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New guidelines on diversity plans for clinical trials will increase the participation of historically underrepresented populations in drug research according to the US Food and Drug Administration (FDA).

The draft guidance document describes the format and content of Diversity Action Plans and sets out the timing and process for submission. It also details the criteria the agency will use to evaluate requests for a waiver.

In a press statement FDA Commissioner Robert Califf said “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data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.”

Diversity in clinical trials has been a focus for the US FDA for the past few years, beginning in April when it introduced its Draft Guidance on Diversity Plans under new provisions of the Federal Food, Drug and Cosmetic Act added by the Food and Drug Omnibus Reform Act (FDORA).

At the time the FDA said the aim was to improve the enrolment of underrepresented populations in trials by encouraging CROs and sponsors to create a framework to define and meet specific diversity goals.

Recruitment goals

The new guidelines provide additional details and make the agency’s expectations clear. For example, sponsors must set recruitment goals for different ethnic groups—stratified by age and gender. The plans should also take into account the prevalence of the disease being treated in the target population.

Richard Pazdur, director of the FDA’s Oncology Center of Excellence which co-developed the new guidelines – suggested the requirement to submit diversity plans may influence drug maker’s R&D decisions.

“These plans may help ensure that sponsors are thinking critically and intentionally about the many characteristics of the patient population they aim to treat when designing their clinical study.”


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