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Bipartisan, Bicameral Congress Members Move to Improve Diversity of Participants in All NIH-Funded Trials

The bill introduction comes ahead of Clinical Trials Day.

Washington, D.C.-(ENEWSPF)- U.S. Senators Bob Menendez (D-N.J.) and Susan Collins (R-Maine), along with Representatives Robin Kelly (D-Ill.-02) and Brian Fitzpatrick (R-Pa.-01), introduced bipartisan, bicameral 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. It will enhance the inclusion of women, racially and ethnically diverse individuals in these trials. Likewise, the bill will ensure the inclusion of people of all ages in all NIH-funded trials.

“Clinical trials play a crucial role in advancing medical knowledge. They improve patient care, and promote better health outcomes for all of us. But the data are clear, marginalized communities are often excluded from the process and are not represented in developing treatments for illnesses that they are dying from disproportionately. We can’t address health disparities if we don’t know have all the facts,” said Rep. Kelly (IL-02). “I am reintroducing the NIH Clinical Trial Diversity Act to ensure that all NIH-funded trials deliver effective and inclusive medical solutions to those who need them most. I am proud that this bipartisan and bicameral legislation, with Rep. Fitzpatrick, Senator Menendez, and Senator Collins, meets this moment and provides the solutions we need to move our pursuit of health equity forward.”

NIH-funded Trials Must Show Treatments, Cures Effective for All

“In order to ensure new drugs, treatments, and cures are effective across all populations, it is critical that NIH-supported studies more equitably include people of all ethnic and racial backgrounds,” said Sen. Menendez. She is a senior member of the Senate Finance Committee that sets national health policy. “The United States is incredibly diverse. This legislation would ensure that all people can benefit from new lifesaving drugs, treatments, and vaccines from NIH-supported trials. The health and future of communities of color, and the entire nation as a whole, would be drastically improved by making clinical trials more representative and inclusive.”

“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.”

Studies Must Include Representation from All Communities

“Studies and clinical trials funded by the NIH must include representation from all communities,” said Rep. Fitzpatrick. “The NIH Clinical Trial Diversity Act will ensure that the agency reaches underrepresented groups of people. It will also boost our ability to make accurate medical conclusions in these studies.”

The Act will:

  • Require NIH to work with clinical trial sponsors to develop clear and measurable recruitment. Seek 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). This will increase the participation of underrepresented populations;
  • Launch a public awareness campaign across federal agencies related to research participation opportunities.

The NIH Clinical Trial Diversity Act is endorsed by the Susan G. Komen Foundation and the Leukemia & Lymphoma Society.

Eliminate Racial Disparities

“Research shows that staggering and unacceptable racial health disparities in breast cancer persist today. One step to addressing health inequities is requiring that clinical trials include diverse participants who are reflective of the populations most impacted by specific diseases and conditions,” said Molly Guthrie, Vice President of Policy and Advocacy at Susan G. Komen. “The NIH Clinical Trial Diversity Act takes a necessary step in the right direction towards tackling these disparities and we applaud Congresswoman Kelly, Congressman Fitzpatrick, Senator Menendez, and Senator Collins for their leadership in ensuring the treatments of tomorrow are safe and effective for all populations.”

“Lawmakers on both sides of the aisle agree: Improving diversity in clinical trials is good science – and common sense. We’re grateful for the leadership of Senators Menendez and Collins and Representatives Kelly and Fitzpatrick on this crucial bill. This will help so many patients,” said Gwen Nichols, MD – Chief Medical Officer of The Leukemia & Lymphoma Society.

Sen. Menendez has long advocated for greater diversity in clinical trials. Sen. Menendez, along with Sen. Tim Scott (R-S.C.), introduced the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Act. This was in August 2021, That bill 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 efforts for clinical trials that can produce new treatments and cures for diseases with a disproportionate impact on underrepresented populations.