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Drs. Bucshon & Ruiz Introduce Clinical Trial Modernization Act

WASHINGTON – On Wednesday, Congressman Larry Bucshon, M.D. (R-IN-08) and Congressman Raul Ruiz, M.D. (D-CA-25) introduced bipartisan legislation (H.R. 8412) 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 last Congress 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.

“I know from my years as a practicing physician how critical it is to have accurate information when providing patients with the care they need,” said Dr. Bucshon. “Success in treating patients relies on effective clinical trials that adequately represent the patient population. I am proud to co-lead the Clinical Trial Modernization Act, which will help promote clinical trial participation among underrepresented populations, and support education, outreach, and recruitment for future trials.”

“As an emergency medicine physician, I know firsthand that individuals respond differently to medications and clinical treatments,” Dr. Ruiz said. “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.”

“Removing barriers to clinical trial enrollment by improving community outreach and ensuring patients aren’t financially penalized or made ineligible for programs like Medicaid because of their involvement in a trial can help improve clinical trial participation among underrepresented communities,” said Lisa A. Lacasse, president of the American Cancer Society Cancer Action Network. “We thank Reps. Ruiz and Bucshon for their leadership in introducing the Clinical Trial Modernization Act, legislation that is critical to our efforts 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:

  1. 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;
  2. Allowing patient cost-sharing by a drug or device manufacturer in a clinical trial when specific criteria are met;
  3. Excluding remuneration for participation in clinical trials from taxable income.

Congressman Larry Bucshon, M.D. represents Indiana’s 8th Congressional District in the United States House of Representatives and is a senior member of the House Energy and Commerce Committee.