Summary
It’s nearly 30 years since the Food and Drug Administration (FDA) Modernization Act of 1997, when Congress instructed the US Health and Human Services (HHS) secretary to consult with the National Institutes of Health (NIH) director and the pharmaceutical industry to “review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials." In this JAMA article, Rita Rubin examines concerns that the Trump administration’s dismantling of diversity, equity, and inclusion (DEI) efforts at the FDA and NIH will result in a reversion back to the days when new treatments were tested mainly in cisgender White men—and not even all shapes and sizes of them.
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