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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.
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  1. Max Kozlov
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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.

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doi: https://doi.org/10.1038/d41586-023-00469-4

References

  1. Hwang, T. J. & Brawley, O. W. N. Engl. J. Med. 387, 1347–1349 (2022).

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  2. Varma, T. et al. BMJ Med. 2, e000395 (2023).

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  3. Vousden, N. et al. BMJ 380, e071278 (2023).

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