Scientific advancements have helped millions of people living with cancer, heart disease, arthritis, obesity, and other diseases. Essential for the development of new therapies are the thousands of people who volunteer to participate in clinical trials every year, helping to characterize the safety and effectiveness of treatments and vaccines.
They raise their hands not knowing if the trial will help, only knowing they will be part of a journey toward possible breakthroughs that will improve or save lives. Yet only about 5% of adults in the U.S. participate in clinical trials. In oncology, the most-researched therapeutic area, a slightly higher percentage of people (7.1%) enroll in treatment trials.
One reason these numbers are so low is because of known barriers to clinical trial participation. These include out-of-pocket costs associated with participation, such as transportation, dependent care, meals, housing, and the like, as well as the time required for taking part, which may mean lost wages. Financial barriers are especially problematic for lower-income households, with individuals who have household incomes less than $50,000 a year being almost 30% less likely to participate in clinical trials.
While financial support from trial sponsors has been identified as a way to address some of these expenses, the uncertainty of the current legal landscape creates potential liabilities for trial sponsors to provide such support and for participants to receive it. We believe these are obstacles Congress can address.
Many clinical trial sponsors offer reasonable payments for time and effort to participants in accordance with Food and Drug Administration guidance. These payments are then combined with reimbursements for expenses to help defray all costs associated with participating in a trial. For example, a sponsor may provide payments for completing e-diary entries and additional time spent participating in clinical trial activities while also reimbursing for travel and hotel expenses. Combining these two types of financial support helps ensure that participants do not incur out-of-pocket costs.
For trial participants who receive $600 or more in payments, sponsors are required to report this income to the Internal Revenue Service (IRS), and participants may owe federal taxes on these payments. These payments may also threaten the eligibility of clinical trial participants for Medicaid benefits or insurance marketplace tax credits because they could be counted against income limits for those programs.
Moreover, while many sponsors provide financial support to patients participating in trials, others don’t, worried that the Civil Monetary Penalty Statute and the Anti-Kickback Statute prohibit such assistance. To date, no legal actions have been taken against sponsors providing incentives or support for trial participation, but clear safe harbors are needed to ensure that all sponsors are comfortable providing financial assistance.
Reps. Raul Ruiz (D-Cal.) and Larry Bucshon (R-Ind.) recently introduced the Clinical Trial Modernization Act (H.R. 8412) into Congress to better address the financial barriers encountered by people with cancer and other life-threatening diseases who participate in clinical trials. Most notably, the bipartisan bill ensures that the first $2,000 in payments a clinical trial sponsor provides to a participant is not subject to taxation and doesn’t count against income limitations for programs such as Medicaid. It also creates a safe harbor for any sponsors who offer such support, ensuring that they would not incur any civil or criminal liability for their actions.
This legislation is sorely needed. A recent analysis conducted by Greenphire, the company one of us (J.M.) leads, of clinical trial payments across 871 trials in the 2023 calendar year showed that people in cancer clinical trials were compensated on average $487.80 for participating in a study.
For the nearly 20% of clinical trial participants in the studies who received payments more than $600, including 12% of those in cancer trials, most, if not all, paid taxes in 2023 on payments they received for volunteering in a clinical trial.
Addressing known barriers to participation is vital for increasing the number and, more importantly, the representation of people who volunteer for clinical trials. Removing the tax burden associated with participation would allow more sponsors to use a combination of payments and reimbursements to help defray all costs associated with volunteering to help create medical innovations. And while offering financial support increases willingness across income levels to participate in clinical trials, it is especially helpful for patients with lower incomes. Additionally, those with cancer who rely on programs like Medicaid and Marketplace subsidies would not have to worry that volunteering for a clinical trial might mean the loss of important benefits.
The Clinical Trial Modernization Act is a concrete step toward easing the financial burdens people may face when enrolling in clinical trials. It also will help ensure that all Americans who want to participate in a trial can do so if they choose, including people from groups that are traditionally underrepresented in clinical trials, like older adults, those with limited incomes, those from certain racial and ethnic groups, and those who live in rural areas. Passing this legislation will support patients and continued medical innovation.
Jim Murphy is the CEO of Greenphire, a clinical trial solutions software company. Lisa Lacasse is president of the American Cancer Society Cancer Action Network, the nonprofit, nonpartisan advocacy affiliate of the American Cancer Society.