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# Report Highlights Study Demographic Representation
- URL: https://www.fdaweb.com/report-highlights-study-demographic-representation/
- Published: 2025-06-27T12:00:00.000Z
- Updated: 2026-09-14T15:15:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159429

A new FDA report breaks down the demographic representation of clinical trials supporting the approval of 50 novel drug therapies approved in 2024, which involved 31,000 clinical trial participants. The [report](https://www.fda.gov/media/187276/download?attachment=&utm%5Fmedium=email&utm%5Fsource=govdelivery), which is intended to provide insight into persistent disparities and areas of progress in clinical research, is part of the agency’s Drug Trials Snapshots transparency initiative. The effort is intended to identify gaps in inclusion and promote more equitable participation in drug development.

The report found that sex representation varies widely by disease area. Among non-sex-specific drug programs, the proportion of female participants ranged from 9% to 98%, with the highest average female enrollment (59%) seen in trials for autoimmune, inflammatory, and lung diseases. Two female-only programs — Lumisight, an imaging agent for breast cancer, and Orlynvah, a treatment for urinary tract infections — were excluded from sex-based analysis due to their intended populations. Likewise, male-only trials for Duchenne muscular dystrophy and hemophilia were also excluded, according to the agency.

Racial representation in the trials showed disparities, with white participants representing the majority in most programs, ranging from 19% to 95%, the report found. Asian participants formed the second largest racial group, particularly in oncology trials, where they made up an average of 44% of enrollees. Black participants had the lowest representation overall, though enrollment reached as high as 68% in trials for neurological and psychiatric disorders.

Regarding the age of trial participants, the report noted that older adults (aged 65 and above) made up 1% to 97% of participants, depending on the disease area. Neurological and psychiatric trials had the highest proportion of older participants, largely driven by enrollment in the Alzheimer’s drug trial for Kisunla, which alone enrolled 90% participants aged 65 or older. In contrast, cancer trials enrolled fewer older adults, with just 36% of participants in that age group.

Additionally, the report found that trials are increasingly global and most of the pivotal trials for the approved drugs were multinational. Cancer drugs (86%) and treatments for reproductive, urologic, and rare metabolic conditions (97%) enrolled the highest proportions of participants from outside the U.S., it said.

FDA emphasized in the report the importance of aligning clinical trial demographics with the U.S. patient population affected by the disease. Doing so, it said, helps identify both barriers and best practices to improve representation in future trials.