Diversity in clinical trials is critically important. Each new treatment needs to be tested in a broad, diverse population, because men and women of different ancestries have different responses to both diseases and treatments. If only certain groups of people participate in clinical trials, it can increase disparities and worsen outcomes for people underrepresented in the clinical trial data.
Until the 1970s, it was common for new medical treatments to be tested only on men. Women, of course, have different hormonal and physical systems and are smaller, on average. Many diseases also have different clinical presentations in women than in men. With women excluded from most clinical trials, doctors lacked important information and could not provide the best quality care. The same situation still exists today for those who have historically been underrepresented in clinical research. While we’ve made progress since 1993, when the National Institutes of Health mandated that women and minorities be included in any government-funded health research, there’s still a long way to go.
To help promote diversity in clinical trials, the FDA has published a number of videos, a blog post, and the infographic (at right). Five of the videos feature Shirley Miller, who is living with sickle cell disease; one features Dr. Luciana Borio, Acting Chief Scientist at FDA; and another is a Spanish-language interview with Cariny Nunez, FDA Public Health Advisor. They share their views on why diversity in clinical trials matters and encourage patients to learn more.
Video 5: Shirley’s Story: Diversity is Critical to Making Better Medical Products(LONG VERSION)
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