More than 100 tissues back off bills to expand patient access to clinical trials
A group of 131 medical organizations unanimously wrote to the U.S. House representatives in support of the recent introduction to the Clinical Trial Modernization Act. The bill is designed to make it easier for patients to participate in clinical trials.
Signatories include the American Cancer Society Cancer Action Network, the National Health Commission, the American Pharmacists Association, the National Coalition of Mental Illness, the Black Cardiologists Association, and more. It is a speech to representatives Raul Ruiz (D-California) and August Pfurger (R-Texas).
Specifically, the bill would allow sponsors to cover medical care (such as copayment) and non-medical expenses (such as travel, accommodation, and parenting) related to clinical trials, and provide patients with digital health tools needed to avoid remote participation.
It will also promote to underrepresented communities through HHS grant support and ensure that no qualification of safety net programs like Medicaid (such as Medicaid) or $2,000 in trial-related financial support is calculated.
“These important provisions are key to increasing clinical trial participation and thus driving innovation and the development of new therapies,” the letter said.
Organizations point out that getting patients to participate in clinical trials is a common challenge. And some groups are often insufficient, such as rural populations, certain races and ethnicities, the elderly, and those with lower incomes.
Cost is also a significant obstacle for many patients, as there are often costs distribution requirements to cover medical trials. Additionally, patients sometimes have to travel so they can participate in clinical trials, which means they have to pay for transportation, accommodation and meals.
This is especially true when it comes to cancer-related clinical trials, as few trials are available locally. The letter notes that due to these costs, there are often differences in participation rates between high-income patients and patients from different geographical locations. For example, cancer patients from families with incomes less than $50,000 per year are 30% less likely to participate in clinical trials.
These organizations point out that providing reimbursement for non-medical expenses such as travel, such as non-medical expenses, may increase participation of underrepresented groups.
“While some trial sponsors provide financial support for non-medical expenses, those often do not worry about violating federal concerns about providing patients with restrictions that can be considered financial incentives,” they said. “For patients, especially low-income patients, receiving financial support may present challenges due to the potential tax burden of any allowance payments, or if incomes believed to be supported by such trials could be denied potentially dequalified by the safety net program.”
Photo: Deidre Blackman, Getty Images
