Study examines effects of state-mandated reimbursement for clinical trials


Enrollment in phase II, but not in randomized phase III, cancer clinical trials increased at a greater rate in states that mandated reimbursement for routine medical costs for trial participants than in states without these policies, according to a new study that appears in the July 21 issue of the Journal of the National Cancer Institute.

Less than 3% of adult cancer patients currently participate in clinical trials. Difficulty in recruiting participants has been cited as the rate-limiting step in conducting these studies, but many factors hinder enrollment. The lack of insurance reimbursement for patient care costs has been identified as one barrier to recruitment. In response, between 1994 and 2001, 15 states passed legislative mandates or entered into agreements with large health plans to ensure that insurers paid for the routine medical costs of clinical trial participants.

To measure the effect of these state policies on cancer clinical trial enrollment, Cary P. Gross, M.D., of the Yale University School of Medicine in New Haven, Conn., and colleagues looked at trends in enrollment in phase II and phase III National Cancer Institute-sponsored Clinical Trials Cooperative Group trials in four states (Illinois, Louisiana, New Jersey, and Virginia) that enacted reimbursement policies in 1999 and in 17 states without such policies.

Although state reimbursement policies were not associated with a substantial increase in overall or phase III clinical trial enrollment, they were associated with an increase in the enrollment in phase II clinical trials. The authors had hypothesized that the state policies would be more likely to impact phase II clinical trial enrollment because these studies are more "experimental" and insurers might be less likely to cover the costs of these treatments.

The authors suggest that the knowledge, beliefs, and attitudes about trials held by physicians and their patients may have a greater influence on participation than state mandates. "Coverage policies may be a necessary but insufficient solution to adequate patient participation in cancer research. To generate a substantial increase in research participation, a multifactorial approach including enhanced community partnerships and public education will be needed," they write.

In an editorial, Bruce E. Hillner, M.D., of Virginia Commonwealth University in Richmond, discusses the issue of cost as a barrier to clinical trial enrollment as well as other potential barriers. "[I]nsurance mandates to require payment for cancer trials address one small hurdle in the long road to increasing enrollment in cancer clinical trials. It is time to shift attention and resources to the numerous other barriers to expanding the foundation of evidence-based oncology care," he writes.

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Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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