The U.S. Senate’s Health, Education, Labor and Pensions committee recently passed a new bill that will address the lack of diversity in clinical trials. Introduced as the Advancing NIH Strategic Planning and Representation in Medical Research Act, the bill will advance several policies to better reflect the diversity of patient populations in studies conducted and funded by the National Institutes of Health.

The majority of patients in most clinical trials are white males, producing results that don’t accurately reflect the proportion of women and minority groups in the world’s population. Medicine that may be effective for white males may not work for women or people of other ethnicities. Furthermore, current knowledge of the health of the LGBTQ communities is extremely lacking. Part of the bill will redouble efforts to study health information of LGBTQ individuals. This legislation takes crucial steps towards strengthening the inclusiveness of biomedical research to provide more accurate data for all communities.

 

The Advancing NIH Strategic Planning and Representation in Medical Research Act:

  • Requires the Director of the NIH to develop and submit a 6-year strategy dubbed the NIH Strategic Plan, which will provide direction to the biomedical research investments made by NIH and facilitate collaboration across the institutes and centers
  • Promotes the inclusion of women and minority groups in research:
    • Requires the directors of the national institutes and centers to consult at least once annually with the Director of the National Institute on Minority Health and Health Disparities and the Director of the Office of Research on Women’s Health
    • Requires the NIH to report to Congress on the number of women and minorities as subjects in trials, and the number trials that included them
    • Ensures that analyses of differing effects of treatments and diseases being studied on women and minorities are reported publicly
  • Establishes a group to “enhance rigor and reproducibility” of NIH-funded research, which will:
    • Consider sex as a biological variable
    • Analyze the diversity of populations studied for research
    • Determine how these factors should be reported
    • How clinical studies should conduct analyses of the data on the study of the factors
  • Establishes a Task Force on Research Specific to Pregnant Women and Lactating Women
  • Encourages and supports research efforts related to the health of sexual and gender minority populations:
    • Directs the NIH and the Department of Health and Human Services to develop and disseminate measures related to reporting health information about sexual and gender minorities
    • Promotes increased participation of sexual and gender minorities in clinical research
    • Facilitates the development of valid and reliable methods for research relevant to sexual and gender minorities
    • Addresses methodological challenges

 

 

You can find the text of the bill here (amended April 18, 2016): https://www.congress.gov/bill/114th-congress/senate-bill/2745/text