Participants in clinical trials deserve more financial support

One reason for these low numbers is known barriers to participation in clinical trials. These include the costs associated with participation, such as travel, care, meals, housing, and the like, as well as the time required to participate, which can result in lost wages. Financial barriers are particularly problematic for low-income households. Individuals with household incomes of less than $50,000 per year are almost 30% less likely to participate in clinical trials.

Although financial support from trial sponsors has been considered as a way to cover some of these costs, the uncertainty of the current legal landscape creates potential liabilities for trial sponsors who provide such support and for participants who receive it. We believe Congress can remove these barriers.

Many clinical trial sponsors provide participants with reasonable payments for time and effort, as required by Food and Drug Administration guidelines. These payments are then combined with reimbursements for expenses to cover all costs associated with participating in a trial. For example, a sponsor may provide payments for completing e-diary entries and additional time to participate in clinical trial activities, while also reimbursing 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 payments of $600 or more, sponsors must report this income to the Internal Revenue Service (IRS), and participants may be required to pay federal taxes on these payments. These payments may also jeopardize clinical trial participants' eligibility for Medicaid benefits or insurance marketplace tax credits, as they could count toward income limits for these programs.

In addition, many sponsors provide financial support to patients participating in trials, but others do not, fearing that the Civil Penalties Act and Anti-Bribery Act prohibit such support. To date, no legal action has been taken against sponsors who offer incentives or support for trial participation, but clear safeguards are needed to ensure that all sponsors consent to the financial support.

Representatives Raul Ruiz (D-Calif.) and Larry Bucshon (R-Ind.) recently introduced the Clinical Trial Modernization Act (HR 8412) in Congress to better address the financial hurdles for people with cancer and other life-threatening diseases participating in clinical trials. Most importantly, the bipartisan bill ensures that the first $2,000 a clinical trial sponsor pays to a participant is nontaxable and does not count toward income limits for programs like Medicaid. It also creates a safe harbor for any sponsors offering such support, ensuring that they are not subject to civil or criminal liability for their actions.

This legislation is urgently needed. A recent analysis of clinical trial payments across 871 trials in calendar year 2023 by Greenphire, the company we (JM) lead, found that individuals in cancer clinical trials were compensated an average of $487.80 for their participation in a trial.

For the nearly 20% of clinical trial participants who received payments of more than $600, including 12% of cancer trial participants, most, if not all, paid taxes in 2023 on payments they received for Volunteering in a clinical study.

To increase the number and—more importantly—representation of people who volunteer for clinical trials, it is essential to remove known barriers to participation. Removing the tax burden associated with participation would allow more sponsors to use a combination of payments and reimbursements to cover all of the costs associated with volunteering for medical innovation. And while offering financial support increases willingness to participate in clinical trials across all income levels, it is especially helpful for lower-income patients. In addition, cancer patients who rely on programs such as Medicaid and Marketplace subsidies would not have to fear that volunteering for a clinical trial could mean losing important benefits.

The Clinical Trial Modernization Act is a concrete step to reduce the financial burdens that can arise from participating in clinical trials. It will also help ensure that all Americans who want to participate in a trial can do so if they choose. This includes people from groups that are traditionally underrepresented in clinical trials, such as older adults, people with low incomes, people from certain racial and ethnic groups, and people who live in rural areas. Passing this bill will support patients and spur further medical innovation.

Jim Murphy is CEO of Greenphirea clinical trial software company. Lisa Lacasse is President of Cancer Action Network of the American Cancer Societythe nonprofit, nonpartisan advocacy organization of the American Cancer Society.