© 2004 by Oxford University Press
© 2004 Oxford University Press
ARTICLE |
Cancer Trial Enrollment After State-Mandated Reimbursement
Affiliations of authors: Sections of General Internal Medicine (CPG, VM) and Cardiovascular Medicine (HMK), Department of Medicine, Robert Wood Johnson Clinical Scholars Program (CPG, HMK), Yale-New Haven Hospital Center for Outcomes Research and Evaluation (CPG, HMK), Section of Health Policy and Administration (HMK), Division of Biostatistics (YL), Department of Epidemiology and Public Health, (HMK) Yale University School of Medicine, New Haven, CT; Department of Health Policy and Administration, University of North Carolina School of Public Health, Chapel Hill, NC (ADK)
Correspondence to: Cary P. Gross, MD, Yale University School of Medicine, Primary Care Center, 333 Cedar St., P.O. Box 208025, New Haven, CT 06520 (e-mail: cary.gross{at}yale.edu)
Background: Recruitment of patients into cancer research studies is exceedingly difficult, particularly for early phase trials. Payer reimbursement policies are a frequently cited barrier. We examined whether state policies that ensure coverage of routine medical care costs for cancer trial participants are associated with an increase in clinical trial enrollment. Methods: 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 1996 and 2001 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. All statistical tests were two-sided. Results: 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. After implementation of the coverage policies in 1999 in four states, there was a 21.7% (95% CI = 3.8% to 42.6%) annual increase in phase II trial enrollment in coverage states, compared with a 15.6% (95% CI = 8.8% to 21.8%) annual decrease in noncoverage states (P<.001). After accounting for secular trend, cancer type, and race in multivariable analyses, the odds ratio (OR) for a phase II trial participant residing in a coverage versus a noncoverage state after 1999 was 1.59 per year (95% CI = 1.22 to 2.07; P = .001). In a multivariable analysis of phase III trial participation, there was a decrease in the odds of residing in a coverage state after 1999 (OR = 0.90, 95% CI = 0.84 to 0.98; P = .011). Conclusion: State coverage policies were associated with a statistically significant increase in phase II cancer trial participation and did not increase phase III cancer trial enrollment.
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Editorial about this Article
- Barriers to Clinical Trial Enrollment: Are State Mandates the Solution?
- Bruce E. Hillner
J Natl Cancer Inst 2004 96: 1048-1049.[Extract] [Full Text] [PDF]
Related Memo to the Media
- Press Release: Study Examines Effects of State-Mandated Reimbursement for Clinical Trials
- Sarah L. Zielinski
J Natl Cancer Inst 2004 96: 1047.[Extract] [Full Text]
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