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Senators Collins, Kim Introduce Bicameral Bill to Expand Participation in Clinical Trials

WASHINGTON, D.C. – U.S. Senators Susan Collins and Andy Kim (D-NJ) introduced the bipartisan NIH Clinical Trial Integrity Act to increase demographic representation in clinical trials funded by the National Institutes of Health (NIH). Companion legislation is also being introduced in the House of Representatives, led by U.S. Representatives Brian Fitzpatrick (R-PA-1) and Robin Kelly (D-IL-2).

“Biomedical research holds tremendous promise for treating many of the most costly and devastating diseases we face. 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,” said Senator Collins. “By encouraging long-term planning and improving demographic representation in clinical studies, this bipartisan legislation would help enhance the effectiveness of critical research that is conducted and sponsored by the NIH.”

“We have a responsibility to ensure Americans of all backgrounds have fair and equal access to treatment and care. This needs to begin with fair and equal representation in the earliest stages of health research and testing, including clinical trials. I hope we can come together to use this legislation as a tool to combat dangerous and persistent health inequities that are putting communities of color and diverse backgrounds at-risk,” said Senator Kim.

Specifically, the NIH Clinical Trial Integrity 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; and
  • Launch a public awareness campaign across federal agencies related to research participation opportunities.

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