A group of 131 healthcare organizations sent a letter on Monday to U.S. House Representatives supporting the recent introduction of the Clinical Trial Modernization Act. The bill aims to make it easier for patients to participate in clinical trials.
The signatories include the American Cancer Society Cancer Action Network, the National Health Council, the American Pharmacists Association, the National Alliance on Mental Illness, the Association of Black Cardiologists and many more. It was addressed to Reps. Raul Ruiz (D-California) and August Pfluger (R-Texas).
Specifically, the bill would allow sponsors to cover both medical (like copays) and non-medical costs (such as travel, lodging and childcare) related to clinical trials, and provide patients with digital health tools needed for remote participation at no cost.
It would also support outreach to underrepresented communities through HHS grants and ensure that up to $2,000 in trial-related financial support is not taxed or counted against eligibility for safety net programs like Medicaid.
“These important provisions are key to increasing clinical trial participation and, thereby, driving innovation and the development of new treatments,” the letter stated.
The organizations noted that getting patients enrolled in clinical trials is a frequent challenge. And some groups are often underrepresented, such as rural populations, certain racial and ethnic groups, older adults and those with lower incomes.
Costs are also a significant barrier for many patients, as there are often cost-sharing requirements in order to be covered for medical trials. In addition, patients sometimes have to travel so they can participate in clinical trials, which means they have to pay for transportation, lodging and meals.
This is especially true when it comes to cancer-related clinical trials, as there are fewer locally available trials. Due to these costs, there is often a disparity in participation rates between high and low-income patients and patients from different geographies, the letter noted. For example, cancer patients from households with an income of less than $50,000 a year are about 30% less likely to enroll in clinical trials.
The organizations stated that offering reimbursement for non-medical costs like travel can increase participation from underrepresented groups.
“While some trial sponsors provide financial support for non-medical costs, those that do not often cite concerns about violating federal restrictions on providing patients with what could be viewed as a financial incentive,” they said. “For patients, especially low-income patients, the receipt of financial support can create challenges with potential tax burdens for any stipend-style payments, or potential disqualification from safety net programs if such trial support is considered income.”
Photo: Deidre Blackman, Getty Images
