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

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