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Medicaid Could Become a Powerful Tool to Improve Racial and Ethnic Representation in Cancer Clinical Trials
One Key May Be Medicaid’s Recent Coverage of the Routine Costs for Enrolling in Clinical Trials
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Diversifying clinical trial participation is a national priority. Federal research institutions, regulators, and Congress have called for efforts to include historically underrepresented populations in clinical studies. Yet ensuring diversity in clinical trials remains challenging for several reasons including limited trust in the health care system, barriers to access, and the financial burden of participating in clinical trials. One potential fix may actually lie where few have looked: Medicaid.
In a recent study, we found an increase in oncology clinical trial participation among Black and Hispanic patients in Medicaid expansion states that mandated Medicaid coverage for the routine costs of trial participation.
Clinical Trial Diversity in Medicaid Expansion Versus Non-Expansion States
Our team, which included William Schpero, Assistant Professor at the Joan and Sanford I Weill Medical College at Cornell University, and LDI Senior Fellow Samuel Takvorian, used a national database of 47,870 nonelderly adult oncology clinical trial participants who were enrolled in a U.S.-based trial from January 1, 2012 to December 31, 2019. The sample included 1,353 clinical trials and 344 clinical trial sites across the country.
We compared states that did not mandate the coverage of routine costs for trial participation to those that did and found that in the years before states expanded Medicaid coverage, the proportion of Black and Hispanic participants enrolled in clinical trials were similar in non-expansion and expansion states. However, in states that had existing coverage mandates, non-expansion states had higher rates of trial participation than states that later expanded Medicaid.
Further analyses showed that over time, the proportion of trial participants who were Black or Hispanic rose in both non-expansion and expansion states. However, Medicaid expansion was associated with a 5.3 percentage point increase in the enrollment of Black or Hispanic participants, specifically in states where Medicaid was required to cover the routine costs of trial participation, but not in states without such mandates. In expansion states without coverage mandates, the increase was only 1.1 percentage point. Medicaid coverage for the routine costs of participating in clinical trials made a difference.
Remove Cost-Related Barriers to Participation
While strategies to improve racial and ethnic representation in clinical trials are needed at every level, this study points to several actions that could reduce financial barriers to participation.
- The findings are relevant to the CLINICAL TREATMENT Act, which mandated that state Medicaid programs cover routine costs of trial enrollees beginning January 1, 2022. Monitoring the implementation of this is important given the decentralized nature of state Medicaid programs. The Centers for Medicare & Medicaid Services could offer guidance based on the experiences of states that offered coverage of trial costs before the 2022 mandate.
- Clinicians serving Medicaid-enrolled patients are a key source of information, referral, and advocacy for patients for whom the enrollment cost is a barrier. Informing clinicians of these policies can reduce implicit and explicit biases that influence enrollment of minoritized and low-income populations in clinical trials.
- The findings of this study also support education and outreach efforts among low-income populations who may find that cost is a barrier to clinical trial participation.
The study, “Association Between State Medicaid Policies and Accrual of Black or Hispanic Patients to Cancer Clinical Trials,” was published on July 25, 2024 in the Journal of Clinical Oncology. Authors include William L. Schpero, Samuel U. Takvorian, Daniel Blickstein, Afrah Shafquat, Jingshu Liu, Arnaub K. Chatterjee, Elizabeth B. Lamont, and Paula Chatterjee.
Author
Paula Chatterjee, MD, MPH
Director, Health Equity Research, Leonard Davis Institute of Health Economics; Assistant Professor, Medicine, Perelman School of Medicine
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