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State-Mandated Reimbursement for Cancer Trial Participation

An often-cited barrier to enrollment in cancer clinical trials is payer reimbursement. Gross et al. (p.1063) examined if state mandates ensuring coverage of routine medical care costs of cancer trial participants increased patient enrollment rates for National Cancer Institute–sponsored phase II and cooperative group phase III trials between 1996 and 2001. They compared enrollment of participants in four states that had enacted coverage policies in 1999 with enrollment in states without policies. After the state mandates were enacted in 1999, the authors found that phase II trial enrollment increased at a greater rate in states with coverage policies compared with states without policies. However, phase III trial enrollment increased at a similar rate in all states, suggesting that coverage mandates were not associated with an increase in phase III trial enrollment.

In an editorial, Hillner (p. 1048) addresses the effect of state mandates that cover patient care costs of clinical trial participation on trial enrollment. He discusses the issue of cost as a barrier to enrollment as well as other potential enrollment barriers.