More com­pa­nies need to set di­ver­si­ty en­roll­ment goals in can­cer tri­als, FDA says

The FDA re­leased draft guid­ance back in April 2022 rec­om­mend­ing that bio­phar­ma spon­sors vol­un­tar­i­ly sub­mit plans to ex­plain how they plan to en­roll their piv­otal tri­als with racial­ly and eth­ni­cal­ly rep­re­sen­ta­tive pop­u­la­tions.

Ac­cord­ing to a slide deck re­leased Tues­day by the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence, about half of the plans from drug­mak­ers re­ceived feed­back from the FDA on what else they need to in­clude.

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