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FDA to require diversity plan for clinical trials

US regulatory agency makes ‘big change’ to increase the number of participants from under-represented groups in drug testing.

By Max Kazlov, Nature

The US Food and Drug Administration (FDA) will soon require researchers and companies seeking approval for late-stage clinical trials to submit a plan for ensuring diversity among trial participants.

Many scientists have applauded the move, which was laid out in a spending bill signed into law by US President Joe Biden in December 2022. They say that broadening participant pools is important to make medicines more effective across the whole population. But they are not yet convinced that the FDA will adequately enforce the new requirement.

Nonetheless, “this is the biggest change in the regulatory landscape for clinical-trial diversity in the last three decades”, says Thomas Hwang, a physician at the Dana-Farber Cancer Institute in Boston, Massachusetts, who has expertise in pharmaceutical regulation. Read more …