When done well, clinical trials can help answer research questions and provide access to cutting edge treatments. They establish standards of care and inform the Food and Drug Administration (FDA) drug approval process. Once a treatment is FDA approved, it becomes eligible for insurance reimbursement and therefore is more accessible. Yet only 2% or 3% of women with breast cancer take part in clinical trials.
- How important are clinical trials in understanding the harms and benefits of new treatments and devices for health conditions?
- Are clinical trials currently set up to ensure that women of color and the elderly are adequately represented?
- How is the FDA taking steps to ensure diversity in clinical trial participants for FDA approved drugs and biologics?
These are important questions that we’ll be talking about in our next webinar, The Trials of Clinical Trials: The Importance of Including Everyone.
Joining us will be two distinguished presenters;
- Galen Joseph, Associate Professor in the Department of Anthropology, History and Social Medicine and Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco and;
- Cindy Pearson, Executive Director of the National Women’s Health Network
All too often, clinical trial participants are overwhelmingly white and male. If not enough women and people of color are included in clinical trials, determining how diverse populations of people are affected by a new drug or device is impossible. Participation in research also offers direct benefits to the participants and underrepresentation of women or communities of color denies them the opportunity to benefit.
We will also be discussing the FDA’s Action Plan to address this glaring shortcoming in clinical trials, as well as where the Action Plan is working and where there are still places for improvement. And last but not least, we will provide opportunities for how and where you can add your voice to make a difference at the FDA.
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