(Reuters) -The U.S. Food and Drug Administration on Wednesday issued guidance to drugmakers and medical device makers on steps to improve racial, ethnic and other diversity in their clinical trials.
The draft guidance lays out the steps for companies and researchers conducting trials to submit goals for study enrollment, separated by age group, ethnicity, sex and race and describe how they intend to meet those goals, the FDA said.
The regulator also laid out the criteria for a waiver against declaring those goals, also known as a diversity action plan.
Clinical trials have had low rates in participation by underrepresented groups including Black Americans despite some groups often having higher rates of certain diseases than the general population.
Such FDA formal guidance, which is not legally binding, is typically followed by companies who are seeking the agency’s approval for their products.
(Reporting by Manas Mishra in Bengaluru; Editing by Shailesh Kuber)
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