BERWYN, PA — Mural Health, a company specializing in patient-first clinical trial technology, is spearheading an initiative to improve access to experimental treatments for millions of Americans on public assistance. The firm has recently announced its plan to work with Congress to establish a gross income exclusion for payments made to participants in clinical trials.
The proposed exclusion would remove tax reporting requirements for payment recipients, including patients and caregivers. This move aims to eliminate a significant hurdle that often deters individuals from enrolling in clinical trials. By doing so, Mural Health intends to enhance the diversity of clinical trial participants and optimize the drug development process.
Clinical trial participants often receive payments to cover expenses and stipends related to certain milestones. These payments are intended to compensate for lost wages and other financial challenges associated with participation in a trial. However, these payments can pose a threat to the eligibility of the roughly 90 million Americans (~27% of the U.S. population) who rely on public assistance programs such as SNAP (food stamps) and Medicaid.
“Current tax requirements unintentionally prevent millions of Americans on public assistance from participating in clinical trials,” says Samuel Whitaker, co-founder and CEO of Mural Health. “This segment of our population includes many of the communities that are underrepresented in clinical trials and the drug development process. They are often forced to choose between enrolling or staying in a trial or maintaining access to benefits they rely on.”
Whitaker has penned a comprehensive letter detailing the issues surrounding income exclusion in clinical trials. This letter, which will be sent to the leaders of the House Ways and Means and the Senate Finance Committees, is currently being circulated among various stakeholders in the clinical research sector. The goal is to gather feedback and rally support for the proposed initiative.
Excluding individuals who rely on public assistance from participating in clinical trials can have far-reaching effects. It impacts not only the critically ill and potential trial participants but also businesses of all sizes and the American public in general.
“Excluding these communities from participation negatively affects a wide array of stakeholders, including the critically ill, prospective trial participants, small and large businesses, and the general American public,” Whitaker explains. “Additionally, this barrier is in direct opposition to the FDA’s effort to diversify enrollment in clinical trials, which is, as they’ve stated, ‘fundamental to public health.’”
Whitaker’s call for income exclusion in clinical trials has garnered support from a wide range of organizations. Various entities, including large and mid-sized pharmaceutical companies, research sites, and other players in the clinical trial arena, have signed onto Whitaker’s letter. This collective push for change underscores the pressing need to make clinical trials more accessible and representative of the broader population, thereby enhancing the effectiveness of new therapies for all Americans.
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