State laws mandating clinical trial reimbursement
We repeated the analysis after stratifying by trial phase because we hypothesized that phase II enrollment might be particularly affected by reimbursement policies due to the increased likelihood that the trials might be perceived as investigational treatment.
We performed a retrospective longitudinal analysis in which we examined trends in participation in National Cancer Institute (NCI)–sponsored phase II and III Clinical Trial Cooperative Group (CTCG) trials from 1996 through 2001.
We used logistic Poisson regressions to analyze enrollment in National Cancer Institute phase II and phase III Clinical Trials Cooperative Group trials and compared changes in trial enrollment rates between 19 of privately insured cancer patients who resided in the four states that enacted coverage policies in 1999 with enrollment rates in states without such policies. Trial enrollment rates increased in the coverage and noncoverage states by 24.9% (95% confidence interval [CI] = 22.8% to 27.0%) and 28.8% (95% CI = 27.7% to 29.8%) per year, respectively, from 1996 through 2001.
Of 91 CCOPs active during this time, 28 were directly affected by coverage mandates.Patients were assigned to states based on their home ZIP code.We excluded patients who lived in one of the 11 states that had enacted policies in other years (either before or after 1999).The impact on patient care is also uncertain because legislation does not usually include a mechanism to evaluate the effect of the mandated coverage.Given the considerable effort and resources that are being invested toward enhancing recruitment to cancer research studies, it is essential to determine which strategies are effective.