FDA Wants Your Clinical Trials to Be More Diverse

By MedTech Intelligence Staff
January 12, 2017


• Categories: 04-Product Design & Development, 05-Quality/Regulatory, RC - Medical Device Audits, Certification & Verification

FDA is reaching out to consumers in the hopes of encouraging more participation among diverse populations. In a recently released consumer update, the agency explains the importance of diversity—to ensure that FDA has an entire view of a product’s benefit or risk. Sounds simple enough, but many patients don’t want to take part in clinical trials due to time, resources or a lack of trust in how they will be treated during a study. However, the FDA points out that there are laws to protect patient rights, along with institutional review boards (an independent committee of people that reviews research plans before research is conducted and once a year, at minimum, during the research). Further hindering patient participation is the fact that there aren’t many physicians who see patients and also conduct clinical research.

“Experience has shown that there can be important differences in how people of diverse groups respond to medical products. Information on those differences can then be included in the product labeling to help doctors and patients make treatment decisions.” – FDA

To encourage more diversity in clinical trials, FDA is working with federal partners, device manufacturers, medical practitioners and health advocates. Initiatives include:

• A clinical trial page specifically designed for patients and what they need to know
• The FDA’s Office of Women’s Health and the NIH Office of Research on Women’s Health are raising awareness among women
• The FDA’s Office of Minority Health has put together specific information to encourage participation among minorities
• Guidance for researchers conducting clinical trials