A recent study published in the Journal of Clinical Oncology indicates that Medicaid expansion under the Affordable Care Act (ACA) is linked to increased enrollment of Black and Hispanic patients in cancer clinical trials, specifically in states that had already mandated Medicaid coverage of routine clinical trial costs. The research, analyzing data from 2012 to 2019, suggests that Medicaid policies play a crucial role in improving equity in clinical trial participation.
The study, co-led by William L. Schpero, Ph.D., from Weill Cornell Medicine, and Samuel Takvorian, M.D., from the University of Pennsylvania, examined deidentified national enrollment data for nearly 50,000 participants in cancer clinical trials. Their findings provide "strong evidence that Medicaid is an important policy lever for improving equity in clinical trials in the United States," according to Schpero.
Impact of Medicaid Policies
The analysis revealed that in states with pre-existing Medicaid coverage mandates, ACA expansion was associated with an approximate 5-percentage-point increase in Black or Hispanic patient enrollment in oncology clinical trials. This highlights the significance of state-level interventions in addressing disparities in trial participation.
Schpero notes that minoritized groups are disproportionately enrolled in Medicaid, with about 35% of Blacks and 31% of Hispanics enrolled in the program among non-elderly adults. This underscores the potential of Medicaid policies to impact access to clinical trials for these populations.
Addressing Financial Barriers
While the study drug costs are generally covered by pharmaceutical companies, patients often face substantial indirect costs, including travel, lodging, and missed work. These costs can average $600 per month, or $7,200 per year, according to a 2015 analysis. A more recent analysis focusing on early-phase clinical trials found that nearly half of enrolled patients incur monthly out-of-pocket costs of at least $1,000.
Recommendations for Improvement
To further enhance equity in clinical trial participation, Schpero and Takvorian suggest that states should utilize Medicaid funding to establish patient navigation programs. These programs can assist individuals in navigating the complexities of trial participation. They also emphasize the need for stronger accountability measures to ensure standardized reporting and transparency regarding the participation of marginalized populations in clinical trials.
Schpero also suggests that state Medicaid agencies and advocacy organizations, such as the American Cancer Society (ACS), should ensure that community oncologists are aware of the federal policy change mandating Medicaid coverage of routine clinical trial costs.
Future Directions
Moving forward, policymakers may consider using their regulatory authority to mitigate the ancillary costs borne by participants in oncology clinical trials. By addressing these financial barriers and implementing targeted interventions, it may be possible to achieve more equitable access to clinical trials for all populations.
