The impact of clinical trial insurance coverage mandates on racial minorities and low income individuals

Mandates are often used as a policy tool to decrease disparities in access to health treatments and services. The lack of insurance coverage for routine care costs associated with participating in clinical trials is often cited as a major barrier to clinical trial participation, especially for low income individuals and racial minorities who are highly cost-sensitive. This article examines if state mandates requiring health insurers to cover routine care costs for patients enroled in clinical trials helped reduce the gap in clinical trial access between the affluent and the poor and between whites and racial minorities. Using data on the locations of cancer clinical trials initiated in the US between 2001 and 2007 as well as Census data on income and race, we examine the effects of the policies on clinical trial sponsors' location choices. Our analysis indicates that the policies helped increase availability of phase 2 clinical trials in areas with a high proportion of black residents, thereby partially mitigating race-based disparity in clinical trial access. We do not find any evidence that the policies helped alleviate income-based disparity in clinical trial access.