Congressmen Ruiz and Pfluger introduce bipartisan Clinical Trial Modernization Act

Washington, D.C. – Today, Congressman Raul Ruiz, M.D. (D-CA) and Congressman August Pfluger (R-TX) announced the introduction of bipartisan legislation to improve participation in clinical trials by underrepresented populations.

The Clinical Trial Modernization Act builds on the successes of clinical trials legislation passed into law in 2022 by addressing economic barriers that can prevent participation in clinical trials. This bill also allows 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 that have a disproportionate impact on underrepresented populations.

“As an emergency medicine physician, I know firsthand that individuals respond differently to medications and clinical treatments,” said Congressman Dr. Raul Ruiz (CA-25). “I am deeply concerned about the potential effects that the lack of participation in clinical trials may have on the effectiveness of new medical treatments and therapies for underrepresented populations. That is why I introduced this important legislation to help ensure clinical trial results are applicable to our nation’s various populations and can lead to more effective treatments.”

"Every American deserves access to the latest medical breakthroughs, regardless of where they live or their economic circumstances," said Congressman August Pfluger (R-TX). The Clinical Trial Modernization Act will remove unnecessary barriers that have prevented many rural and underserved communities from participating in critical research, ultimately delivering more effective treatments to all Americans. I'm proud to partner with Dr. Ruiz on this bipartisan solution that will both improve health outcomes and strengthen America's position as a global leader in medical research." 

“No one should be disadvantaged in their cancer journey,” said Lisa A. Lacasse, president of the American Cancer Society Cancer Action Network. “The Clinical Trial Modernization Act would help eliminate cost and geographic barriers to clinical trials, making it easier for all people with cancer to participate in clinical trials. We thank Reps. Pfluger and Ruiz for their leadership in introducing this legislation, which is critical to our work to reduce the cancer burden for everyone.”

The Clinical Trial Modernization Act would make strides towards ensuring all populations can benefit from novel therapeutics.

The Clinical Trial Modernization Act will address economic barriers to participation in clinical trials by:

• Exempting free digital health technology that enables trial participation from the Anti-Kickback statute when doing so will facilitate clinical trial participation by underrepresented populations;
• Allowing patient cost-sharing by a drug or device manufacturer in a clinical trial when specific criteria are met;
• Excluding remuneration for participation in clinical trials from taxable income.