USA – Older adults, Black patients underrepresented in post-marketing studies

In postmarketing studies of cancer therapies approved by the US Food and Drug Administration (FDA), representation of older adults and Black patients does not appear to be improved compared with premarketing studies, a recent investigation in JAMA Network Open suggests.

In addition, the sex and race of participants were identified less frequently in postmarketing studies than premarketing studies, according to a cross-sectional analysis of 77 premarketing and 56 postmarketing studies of FDA-approved cancer therapies between 2012 and 2016 by Tanvee Varma, BA, of the Yale School of Medicine in New Haven, CT, and colleagues.

“Inadequate demographic representation in premarketing and postmarketing studies calls into question the generalizability of cancer clinical trial results to clinical practice as well as the FDA’s ability to encourage or enforce demographic representation in clinical studies,” Varma and colleagues said…