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June 28, 2024

FDA guidance calls for greater diversity in clinical trials

The U.S. Food and Drug Administration on Wednesday recommended steps for drugmakers and medical device makers to improve racial, ethnic and other diversity in their clinical trials (Source: “US FDA recommends steps to improve diversity in clinical trials,” Reuters, June 26).

The draft guidance includes suggestions for companies and researchers conducting trials on how to set goals for study enrollment, separated by age group, ethnicity, sex and race, and describe how they intend to meet those goals, the FDA  said.

"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," said Richard Pazdur director of FDA's Oncology Center of Excellence.

FDA's guidance, which is not legally binding, is typically followed by companies seeking the agency's approval for their products.