Women's Health Research > Women’s Participation in Clinical Trials

Women’s Participation in Clinical Trials
Status of Women’s Participation in Clinical Trials

In 1992 and 2001, the General Accounting Office (GAO) issued reports that examined the participation of women in clinical trials for new drugs submitted to the FDA. Two subsequent OWH-supported studies provided updates to the GAO data. Since the first GAO report, women’s participation has improved to approximately 50% in late phase clinical trials. Women’s participation in late-phase clinical drug trials was reported at 46% in 1992, 55% in 2001, and 49% for drugs approved in 2000-2002. Participation in early phase trials has increased from 22% (1998-2000) to 31% (2006-2007). Sex-based data analysis has also improved since 1992.

To Learn More:

Status of Women’s Participation in Clinical Trials. Journal of Women’s Health, 2010; 19:1771.

OWH advocates for participation of women in clinical trials and the analyses of data by sex.

* Adequate participation of women in clinical trials allows representation of the population most likely to use a disease therapy.
* Analyzing data by sex allows researchers to determine if there are any sex differences in a disease therapy.
* Sex differences can include differences in disease prevalence and response.
* Analyses for sex differences can provide insight into the scientific basis for individual therapy differences and provide future directions for research.

OWH R&D program supports studies to track participation of women in clinical trials and collaborate with FDA centers to understand sex and gender differences in disease prevalence and response to therapy through science and research. FDA Center collaborations contribute towards the development of MaPPs, guidances and regulations to advance women’s health.

Past OWH Funded Studies Examining Participation of Women in Clinical Trials (21 KB pdf)
http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/WomensHealthResearch/UCM135445.pdf

OWH Collaborations Examining Participation of Women in Clinical Trials

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Women's Health Research > Women’s Participation in Clinical Trials