WASHINGTON, DC – May 15, 2024 – Federal legislation that would make it easier for all cancer patients to participate in clinical trials was introduced today in the House. Sponsored by Reps. Raul Ruiz (D-Calif.) and Larry Bucshon (R-Ind.), the Clinical Trial Modernization Act is bipartisan legislation that would increase access to clinical trials by helping remove cost and geographic barriers to patient participation.
The legislation would allow clinical trial sponsors to provide financial support to patients for costs associated with their trial participation, including medical cost-sharing like copays, and non-medical expenses such as travel, parking, food and lodging. It would also allow trial sponsors to provide patients with the necessary technology to facilitate remote participation in clinical trials. These provisions would help ensure 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, certain racial and ethnic groups and people who live in rural areas.
According to an ACS CAN survey of cancer patients and survivors, 79 percent of respondents indicated they would be more likely to enroll in a clinical trial if sponsors supported them financially to offset non-medical costs. Eighty percent said they would be willing to use remote technologies and tools in a trial.
“Clinical trials are essential for continuing to improve cancer prevention, detection, treatment and survivorship, but are out of reach for far too many patients,” said Lisa A. Lacasse, president of the American Cancer Society Cancer Action Network (ACS CAN). “The Clinical Trial Modernization Act can give more patients—regardless of how much money they make or where they live—a chance to enroll in the best treatment options available by reducing barriers to enrollment due to cost and access issues.”
The legislation would also amend the Internal Revenue Code so that stipends or other forms of payments like per-diems that are provided by a trial sponsor, up to $2000, are not considered as taxable income or counted against income limits for programs such as Medicaid.
Additionally, the U.S. Department of Health and Human Services (HHS) would be able to provide grants for community education, outreach and recruitment activities to enable greater clinical trial engagement with underrepresented populations. Grant-eligible activities would include working with community trial sites and 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 serving those communities.
“The Clinical Trial Modernization Act will help improve access to lifesaving clinical trials and help accelerate 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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