FDA Voice on Clinical Trial Diversity
FDA Brief: Week of Jan 25, 2016
2016: The Year of Diversity in Clinical Trials
By: Robert M. Califf, M.D., FDA’s Deputy Commissioner for Medical Products and Tobacco
- Increasing diversity in clinical trials is a priority for FDA
- Research participants need to be representative of patients who will use product
- FDASIA Section 907 :
- evaluate underrepresented groups e.g. elderly, women, racial/ethnic
- FDA Activities:
- Drug Trial Snapsots publication on clinical trial demographic information
- Office of Minority Health tools for clinical trial participation
- Office of Women’s Health’s Diverse Women in Clinical Trials initiative
- Better estimates of treatment effects for diverse populations
- Obtain patient’s perspective
- Office of External Affairs plans to publish a consumer update