Fortune, April 7, 2021. There’s a big problem with clinical trials: a lack of diversity. This problem led researchers to believe that Black women did not develop breast cancer as frequently as white women and created a gap in understanding how different treatments work. How can companies like Genentech start increasing diversity in clinical trials?
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NCHR’s Comments on FDA’s Draft Guidance on Levonorgestrel
March 23, 2020: A diverse participant population is necessary for the results to be relevant to women of different races, ethnicities, and BMI.
Read More »NCHR’s comments on FDA’s Draft Guidance for Industry on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
March, 19, 2020: The FDA’s draft guidance describes circumstances under which exceptions can be made to the requirement of two adequately controlled clinical trials. Although the law allows these exceptions under certain circumstances, we have concerns over the frequency with which these exceptions are made.
Read More »NCHR Comments on FDA’s OMHHE Strategic Priorities
February 28, 2020. Efforts to improve inclusion of racial and ethnic minority populations in clinical trials need to include incentives that are more effective than merely asking companies to do so. Greater diversity would, in turn, improve the generalizability of clinical trial results and provide patients and health care professionals with the information necessary to make an informed decision about which products to use for which patients.
Read More »Everything is designed for men, even drugs
Vox, January 16, 2020. Designing medicine around the “average man” is so dangerous. We need more inclusivity in clinical trials — for women, for people over 65, and for people of color.
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