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U.S. Department of Health and Human Services

About FDA

Women's Participation in Clinical Trials

Description: Report levels of activity regarding women's participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, and biological products across where appropriate, age, biological, and sociocultural contexts. (1)

Accomplishment: Findings from these studies will inform on participation of women in clinical trials as well as analysis for safety and efficacy in women vs. men. These determinations will subsequently address women’s treatment needs, and optimize the risk benefit ratio. Findings from funded studies will expand the knowledge base with regard to sex differences in disease prevalence and response to treatment. This will subsequently inform labeling and catalyze further research to understand sex differences and women’s health issues.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Support studies to track the participation of women in clinical trials and collaborate with FDA Centers to understand sex differences in disease prevalence and response to treatment

Ongoing

Completed 4/30/2010 (and ongoing)

2. Assess applications FDA Centers receive for sex based analysis

Ongoing

Ongoing Ongoing

a. Award intramural funding for Phase I and II (Study Analysis) to the Center for Drug Evaluation and Research (CDER)

4/30/2010

Completed 4/30/2010

b. Complete Phase III (Tracking) for 2007, 2008, and 2009

11/30/2010

Completed 11/30/2010

c. Initiate Phase III (Sex-Based Analysis)

2/28/2011

Completed 2/28/2011

3. Evaluate Office of Women’s Health (OWH) funded studies in various therapeutic areas (e.g., cardiovascular disease, oncology, medical devices, diagnostic tests, biologics, etc.)

9/30/2010

Completed 11/30/2010

Footnotes

  • (1) This OWH project is an ongoing effort. The milestones listed are only the most recent examples of OWH's work in this area.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.