In a Monday letter, 195 patient advocacy, public health and healthcare professional organizations endorsed the Clinical Trial Modernization Act, which seeks to increase access to clinical trials for underrepresented groups.
The organizations include the American Cancer Society Cancer Action Network, the American Lung Association, the American Pharmacists Association, the National Alliance on Mental Illness, the National Black Nurses Association and more.
The Clinical Trial Modernization Act was introduced in the Senate by Senators Mark Warner (D-Virginia) and Tim Scott (R-South Carolina) and in the House by Representatives Raul Ruiz (D-California) and August Pfluger (R-Texas). It would reduce economic barriers to participating in clinical trials by permitting sponsors to provide financial support for travel, lodging, childcare, copays and coinsurance. It would also allow sponsors to provide remote patient monitoring tools at no cost to support remote participation in clinical trials.
In addition, it would expand enrollment of underrepresented groups by allowing the Department of Health and Human Services to provide grants for community education, outreach and recruitment. Lastly, the bill would protect patients from financial hardship by excluding up to $2,000 in financial assistance from federal income taxes and eligibility calculations for safety-net programs like Medicaid.
“These provisions will help reduce bureaucratic and financial barriers to participation, increase accessibility to clinical trials, and ultimately strengthen U.S. leadership in medical innovation,” the groups said. “By improving enrollment, the legislation will accelerate the development of new treatments, benefiting both trial participants and the broader public.”
Currently, many underrepresented populations — including racial and ethnic groups, older adults, rural populations and those with lower incomes — are unable to enroll in clinical trials due to costs. Insurers often cover routine medical costs for clinical trials, but patients are frequently on the hook for cost-sharing and non-medical expenses like transportation and lodging.
The letter noted that one recent study shows that people earning less than $38,000 a year were 36% less likely to enroll in prostate cancer clinical trials, 47% less likely to enroll in kidney cancer trials and 71% less likely to enroll in bladder cancer trials than those earning more than $63,000.
“Studies also show that reimbursing patients for non-medical costs can increase overall enrollment and improve participation among underrepresented groups. Although some trial sponsors provide such financial support, others refrain due to confusion around federal restrictions on patient incentives,” the letter stated. “Even when support is offered, patients—particularly those with lower incomes—may face unintended consequences, such as tax liability or the risk of losing eligibility for safety net programs like Medicaid.”
Photo: Deidre Blackman, Getty Images
