The Food and Drug Administration has drafted guidance aimed at getting drug companies and medical device makers to enroll more people of color and women in the clinical trials that test whether products work.
The guidance is long-awaited. It’s the first step in carrying out a law that Congress passed in 2022, and it’s six months late. Congress sought to fix the chronic lack of diversity in clinical research by requiring that companies give the FDA their plans for enrolling patients who are representative of the patients who would take the products being tested.
When trials fail to include the people most affected by the diseases that a product treats, it undermines research and leaves doctors and patients without needed information for decisions about their health care, according to the National Institutes of Health.
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