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U.S. Senators Susan Collins (R-ME) and Bob Menendez (D-NJ) introduced bipartisan legislation on Dec. 30 to increase the diversity of participants in all National Institutes of Health (NIH)-funded trials. The NIH Clinical Trial Diversity Act builds upon the NIH’s current policies to enhance the inclusion of women, racially and ethnically diverse individuals and people across the lifespan in all NIH-funded trials. This bill would build on a law Senator Collins co-authored in 2016 that promotes the inclusion of women and minorities in clinical research.

“Biomedical research holds tremendous promise for treating many of the most costly and devastating diseases we face,” said Senator Collins.  “To ensure that the benefits of cutting-edge medical science reach all Americans, it is important that participants in clinical trials reflect our overall population.  By encouraging long-term planning and improving demographic representation in clinical studies, this bipartisan legislation will help enhance the effectiveness of critical research that is conducted and sponsored by the NIH.”

“The COVID-19 pandemic, which disproportionately hit minority communities, has shone a light on the lack of diversity in clinical trials,” said Senator Menendez. “It is critical that NIH-supported studies on lifesaving drugs, treatments, and vaccines must include people of all ethnic and racial backgrounds. Having more diverse clinical trials would improve the health of communities of color and the nation as a whole.”

The NIH Clinical Trial Diversity Act would:

  • Require NIH to work with clinical trial sponsors to develop clear and measurable recruitment and retention goals based on disease/condition prevalence as well as a rationale for specified goals and a recruitment plan;
  • Ensure the availability of less burdensome follow-ups during clinical trials (e.g. fewer follow ups, phone participation, weekend hours) to increase participation of underrepresented populations;
  • Launch a public awareness campaign across federal agencies related to research participation opportunities.

Representatives Robin Kelly (D-Ill.-02) and Brian Fitzpatrick (R-Pa.-01) introduced companion legislation in the House of Representatives earlier this year.

The NIH Clinical Trial Diversity Act is endorsed by the American Cancer Society Action Network, American Psychological Association, Association of Black Cardiologists, Beyond Celiac, Doctors for America, FasterCures, Leukemia & Lymphoma Society, National Organization of Rare Diseases, Susan G. Komen Foundation, No Health without Mental Health, Society for Public Health Education (SOPHE), Touch, the Black Breast Cancer Alliance, and Verily.

Author: Press Release


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