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# FDA Should Require Better Cancer Drug Trial Representation: Study
- URL: https://www.fdaweb.com/fda-should-require-better-cancer-drug-trial-representation-study/
- Published: 2021-04-29T12:00:00.000Z
- Updated: 2026-09-14T16:56:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149225

Academic medical center researchers from Yale and other institutions say older Americans and blacks are underrepresented in both premarketing and postmarketing trials for a variety of cancer therapeutics. “FDA should require demographic representation in premarketing and postmarketing studies that approximates the population expected to use the therapeutic by investing in adequate recruitment a priori to ensure that ensuing demographic representation does not risk delaying study completion for new drugs,” the researchers write in a *JAMA Open Network* [report](https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2778908?ref=fdaweb.com).

The article says that while FDA published several guidelines from 2014 to 2020 for improving reporting and participation of women, older patients, and racial and ethnic minority groups in clinical research, “our findings suggest that translating these guidelines into practice remains a challenge.”

The analysis found that in 77 premarketing studies and 56 postmarketing studies for FDA-approved cancer therapeutics, there was inconsistent reporting of demographic data and underrepresentation of older adults and black patients. The researchers say it appears that postmarketing studies are not associated with improvements to gaps in demographic representation present at the time of FDA approval.