title: Cancer trial enrollment after state-mandated reimbursement.
abstract: 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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Sections of General Internal Medicine, Yale University School of Medicine, New Haven, CT 06520, USA. cary.gross@yale.edu
authors.forename: C P
authors.initials: CP
authors.lastname: Gross
authors.forename: V
authors.initials: V
authors.lastname: Murthy
authors.forename: Y
authors.initials: Y
authors.lastname: Li
authors.forename: A D
authors.initials: AD
authors.lastname: Kaluzny
authors.forename: H M
authors.initials: HM
authors.lastname: Krumholz
mesh_terms: D001943:Breast Neoplasms / Q000191:economics / Q000628:therapy; D017322:Clinical Trials, Phase II as Topic / Q000191:economics / Q000331:legislation & jurisprudence; D017326:Clinical Trials, Phase III as Topic / Q000191:economics / Q000331:legislation & jurisprudence; D015179:Colorectal Neoplasms / Q000191:economics / Q000628:therapy; D005260:Female; D033161:Government Regulation; D006801:Humans; D015994:Incidence; D016015:Logistic Models; D008137:Longitudinal Studies; D008175:Lung Neoplasms / Q000191:economics / Q000628:therapy; D008297:Male; D015337:Multicenter Studies as Topic / Q000191:economics / Q000331:legislation & jurisprudence; D009316:National Institutes of Health (U.S.); D009369:Neoplasms / Q000191:economics / Q000453:epidemiology / Q000628:therapy; D018579:Patient Selection; D016012:Poisson Distribution; D011471:Prostatic Neoplasms / Q000191:economics / Q000628:therapy; D012051:Reimbursement Mechanisms / Q000331:legislation & jurisprudence*; D012189:Retrospective Studies; D013219:State Government; D014481:United States / Q000453:epidemiology