WASHINGTON, D.C. – May 20, 2025 – New federal legislation that would make it easier for all cancer patients to participate in clinical trials was introduced today in the House of Representatives. Sponsored by U.S. Reps. Raul Ruiz (D-Calif.) and August Pfluger (R-Texas), the Clinical Trial Modernization Act would help remove cost and geographic hurdles that prevent patients from participating in clinical trials.
The legislation would enable clinical trial sponsors to provide financial support to patients for costs associated with their trial participation, including medical expenses like copays, and non-medical expenses such as travel, parking, food and lodging. It would also allow trial sponsors to provide patients with the technology needed to facilitate remote participation in clinical trials. These provisions would help make sure that all patients are able to participate in clinical trials, including those who are underrepresented in clinical trials, like older adults, people with limited incomes, people who live in rural areas and certain racial and ethnic groups.
According to an American Cancer Society Cancer Action Network (ACS CAN) survey, 79% of cancer patients and survivors indicated they would be more likely to enroll in a clinical trial if sponsors supported them financially to offset non-medical costs. Similarly, willingness to enroll in a clinical trial increased among cancer patients and survivors when informed that they could use remote technologies to decrease the need for in-person visits and other appointments. This was true even among cancer patients and survivors who initially said they would not enroll in a clinical trial.
“Clinical trials are essential for continuing to improve cancer prevention, detection, and treatment, but far too many patients are unable to access trials due to cost and geographic barriers,” said Lisa A. Lacasse, president of ACS CAN. “The Clinical Trial Modernization Act will help ensure that all patients have a chance to enroll in the best treatment options available without having to bear additional costs or inconveniences.”
The legislation would amend the Internal Revenue Code so that stipends or other forms of payments like per-diems that are provided by a clinical trial sponsor -- up to $2,000 -- are not considered as taxable income or counted against income limits for programs such as Medicaid. It also clarifies that such support by sponsors is permitted under anti-kickback laws.
In addition, the legislation would allow the U.S. Department of Health and Human Services (HHS) to provide grants for community education, outreach and recruitment activities to enable greater clinical trial participation from people who currently are underrepresented in clinical trials. Grant-eligible activities would include working with local trial sites like community health centers, training health care personnel and clinical trial investigators, engaging community stakeholders to encourage clinical trial participation and fostering partnerships with community-based organizations.
“The CTMA will help improve access to lifesaving clinical trials, accelerating the development of new and better treatment options for all patients,” said Lacasse. “We urge Congress to quickly take up this bill and pass it into law.”
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