The FDA has released the latest draft outlining new requirements for how pharmaceutical and medical device companies should consider race and ethnicity when designing clinical trials. The new requirement is mandated by a recent law, the Food and Drug Omnibus Reform Act, better known as the FDORA Act.
In the past, many clinical trials haven’t included enough people from different racial and ethnic backgrounds, primarily focusing on white men. This can be a problem because many medications and devices may affect people of varying races differently. The FDA emphasizes that including more diverse participants not only benefits these groups but also improves the overall understanding of the disease or treatment being studied.
New FDA clinical trial requirements
The FDA’s draft guidance asks companies to develop “Diversity Action Plans.” These plans will need to explain:
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- How many people from different racial and ethnic groups the company aims to recruit for their trials, considering factors like age and sex.
- Why they chose these goals and how they plan to reach them.
The FDA also suggests ways companies can increase diversity in their trials, such as:
- Partnering with community groups
- Making trials more accessible (e.g., providing transportation)
- Choosing trial sites in diverse areas
- Offering flexible trial schedules to accommodate more participants
“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,” Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a press release.
Who does this apply to? These plans will be mandatory for larger, late-stage clinical trials. The FDA also encourages companies to consider diversity throughout the entire development process, from the very beginning. Companies can request a waiver from submitting a Diversity Action Plan, but there will be a significant process for evaluating these requests.
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What happens next? The public can comment on the draft guidance until September 26th. Once finalized, companies that begin enrolling people in trials six months after that must submit these Diversity Action Plans.
Overall, this is a step towards ensuring that new medical treatments are safe and effective for everyone, but especially Black Americans.
