STAT+: FDA poised to publish guidelines for clinical trial diversity

The Food and Drug Administration is poised to tell drug and medical device makers how to better include people of color in the clinical trials that test whether products work and are safe, an agency official said Wednesday. Those guidelines are five months late.

To ensure that drugs work for everyone, they must be tested on a representative sample of people. But researchers have found that many clinical trials exclude the people of color who are often most affected by the diseases that drugs treat.

To help fix that problem, Congress passed a law requiring companies to give the FDA their plans for diversifying clinical trials. As part of that process, the agency was expected to issue guidance by April 10.

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