Clinical trials are an important way to develop new and better treatments for care. By participating in a clinical trial, patients can help advance research and potentially improve their own care. According to the National Cancer Institute (NCI), approximately 9% of adult patients are invited to participate in clinical trials. The number of clinical trials for cancer comprises between 40 to 50% of all trials in the U.S. which dwarfs that of any other single disease. At the same time, 66% of oncology clinical trials close prematurely because they cannot fill their trials with patients. In April 2023, the U.S. Department of Health and Human Services released the National Cancer Plan which “supports strategies to increase the representation of all populations in cancer research and ensure that every person benefits equitably from cancer research and clinical advancements.” Increasing access and ensuring more underrepresented populations in clinical trials are strategic priorities for research institutions.

Although clinical trial enrollment involves complex processes, research institutions can increase enrollment and patient diversity by identifying and resolving financial and social related barriers. For example, site of care impacts clinical trial opportunities and enrollment. While there are trials available at community hospitals, Academic Medical Centers and NCI Comprehensive Cancer Centers offer the majority of open clinical trials outside of the immediate service area, which creates significant travel barriers. According to The Oncologist, the greatest travel burden is for patients enrolled in NCI-sponsored trials, Phase I studies or those living in low-income areas.

Clinical Trials and Financial Toxicity  

Financial toxicity encompasses the various hardships patients and families experience regarding treatment and care costs. Most participants in clinical trials experience financial toxicity, but Cancer Clinical Trial (CCT) participants are especially high risk. Harvard published a study in the Journal of Clinical Oncology: 57% of CCT patients reported financial burden and 41% reported having trial cost concerns. Two recent studies showed that patients with household income less than $50,000 per year were 27% less likely to participate in clinical trials. Patients with fewer financial resources may find the direct and indirect costs of clinical trial participation, such as travel, time off from work or childcare to be very prohibitive. Trial sponsors provide payment for specific elements of clinical trials and the Affordable Care Act requires coverage of the routine costs, but many clinical trial participants still have associated medical costs billed to their health insurance. Leveraging patient assistance programs can help ensure patients stay in the clinical trial and avoid any associated financial toxicity.

In addition to cost and insurance obstacles, disparities in trial enrollment exist along age, ethnic and sociodemographic lines, with younger, poorer, non-white, and underinsured patients – the exact population who may be at highest risk for financial toxicity—less likely to participate. To increase participation, research centers must identify and resolve all barriers to care and clinical trial participation. This includes health-related social needs such as financial burden, travel, food, housing and childcare.  

How to improve clinical trial health equity

Based on the current statistics, research institutions have a significant opportunity to improve clinical trial participation and diversity. Utilizing technology is one strategy to increase access to clinical trials and reduce financial toxicity for participating patients. Patient advocates can use technology to collaborate with charitable foundations to improve health equity in clinical trials by providing assistance to cover the incremental costs of clinical trial participation. This technology enables advocates to efficiently and proactively address systemic barriers by identifying and enrolling patients in philanthropic aid programs. In doing so, patient advocates can increase patient access to financial support for costs associated with standard treatment and incremental costs of clinical trial participation, such as transportation, food, housing and/or childcare.