Why women of color are needed in FDA clinical trials

Clinical trials have historically been a negative experience for people of color, with the infamous Tuskegee syphilis study as the most egregious example. As a result, the African-American community is reluctant to participate in clinical trials, and the research community has been similarly hesitant when recruiting minority populations for clinical trials. The Food and Drug Administration (FDA), however, is the only agency within the U.S. Department of Health and Human Services that does not require a representative sample of people of color in research studies. The combination of the reluctance of people of color to participate, and the lack of any requirements of representation has resulted in many medical products being approved without adequate data on their safety and effectiveness for people of color. For example, a medical device that treats uterine fibroids, a condition that is much more common among African American women than white women, was approved by the FDA despite the lack of women of color in the clinical trials that were the basis of approval.

Communities of color are hardest hit by hypertension, diabetes, cardiovascular disease, stroke, and cancer. Gender specific cancers-- prostate and breast-- have higher mortality rates for African-American men and women, respectively, than in any other ethnicity. In recent years the FDA has recommended that companies testing medical products specify the race of study participants, but until FDA requires adequate representation to ensure safety and effectiveness, it is likely that health disparities will continue.