Source: United States Senator for New Jersey Bob Menendez
WASHINGTON, D.C. – U.S. Senators Bob Menendez (D-N.J.) and Susan Collins (R-Maine) today introduced bipartisan legislation 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.
“The COVID-19 pandemic, which disproportionately hit minority communities, has shone a light on the lack of diversity in clinical trials,” said Sen. Menendez, the highest ranking Latino in Congress and a senior member of the Senate Finance Committee that sets national health policy. “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.”
“Biomedical research holds tremendous promise for treating many of the most costly and devastating diseases we face,” said Sen. 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 NIH Clinical Trial Diversity Act will:
- 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.
Sen. Menendez has long pushed for greater diversity in clinical trials. In August 2021, Sen. Menendez, along with Sen. Tim Scott (R-S.C.), introduced the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Act, which would allow the U.S. Department of Health and Human Services (HHS) to issue grants or enter into contractual arrangements to support education, outreach and recruitment for clinical trials for diseases with disproportionate impact on underrepresented populations.