FDA Brief: Week of Jan 25, 2016

FDA Voice

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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