White Paper

Women-Centric Approach To Clinical Trials

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For decades, women were left out of clinical trials, despite the fact that they often process drugs differently than men due to their size, biology, and physiology. It wasn’t until 1993 that the NIH Revitalization Act mandated women and minorities be included in clinical trials funded by the federal government.

This has resulted in limited historical data about how women respond to drugs and other treatments, creating health risks for women and financial risks for developers. The U.S. Government Accountability Office (GAO) determined that 80 percent of drugs pulled from the market due to unacceptable health risks between 1997 and 2000 were found to be more harmful to women than to men. New research is beginning to quantify the magnitude of these risks.

Whether the focus is on female participants or supporting participant diversity, drug developers can benefit from adapting outreach strategies that inspire empathy with the patient community. Partnering with female-driven or ethnically-focused patient advocacy groups to craft outreach messages and communicate the safety, value, and expectations of trial participation, along with using social media to share real-life stories of women who have participated in trials, can help make meaningful and emotional connections with potential participants.

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