title: Measuring the incremental cost of clinical cancer research.
abstract: OBJECTIVE
  To summarize evidence on the costs of treating patients in clinical trials and to describe the Cost of Cancer Treatment Study, an ongoing effort to produce generalizable estimates of the incremental costs of government-sponsored cancer trials.
  
  
  METHODS
  A retrospective study of costs will be conducted with 1,500 cancer patients recruited from a randomly selected sample of institutions in the United States. Patients accrued to either phase II or phase III National Cancer Institute-sponsored clinical trials during a 15-month period will be asked to participate in a study of their health care utilization (n = 750). Costs will be measured approximately 1 year after their trial enrollment from a combination of billing records, medical records, and an in-person survey questionnaire. Similar data will be collected for a comparable group of cancer patients not in trials (n = 750) to provide an estimate of the incremental cost.
  
  
  RESULTS
  Evidence suggests insurers limit access to trials because of cost concerns. Public and private efforts are underway to change these policies, but their permanent status is unclear. Previous studies found that treatment costs in clinical trials are similar to costs of standard therapy. However, it is difficult to generalize from these studies because of the unique practice settings, insufficient sample sizes, and the exclusion of potentially important costs.
  
  
  CONCLUSIONS
  Denials of coverage for treatment in a clinical trial limit patient access to trials and could impede clinical research. Preliminary estimates suggest changes to these policies would not be expensive, but these results are not generalizable. The Cost of Cancer Treatment Study is an ongoing effort to provide generalizable estimates of the incremental treatment cost of phase II and phase III cancer trials. The results should be of great interest to insurers and the research community as they consider permanent ways to finance cancer trials.
authors.affiliation: RAND, Santa Monica, CA 90407-2138, USA. dgoldman@rand.org
authors.forename: D P
authors.initials: DP
authors.lastname: Goldman
authors.forename: M L
authors.initials: ML
authors.lastname: Schoenbaum
authors.forename: A L
authors.initials: AL
authors.lastname: Potosky
authors.forename: J C
authors.initials: JC
authors.lastname: Weeks
authors.forename: S H
authors.initials: SH
authors.lastname: Berry
authors.forename: J J
authors.initials: JJ
authors.lastname: Escarce
authors.forename: B A
authors.initials: BA
authors.lastname: Weidmer
authors.forename: M L
authors.initials: ML
authors.lastname: Kilgore
authors.forename: N
authors.initials: N
authors.lastname: Wagle
authors.forename: J L
authors.initials: JL
authors.lastname: Adams
authors.forename: R A
authors.initials: RA
authors.lastname: Figlin
authors.forename: J H
authors.initials: JH
authors.lastname: Lewis
authors.forename: J
authors.initials: J
authors.lastname: Cohen
authors.forename: R
authors.initials: R
authors.lastname: Kaplan
authors.forename: M
authors.initials: M
authors.lastname: McCabe
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics*; D017322:Clinical Trials, Phase II as Topic / Q000191:economics; D017326:Clinical Trials, Phase III as Topic / Q000191:economics; D017048:Health Care Costs; D006285:Health Planning; D006297:Health Services Accessibility; D006801:Humans; D019458:Insurance Coverage; D007348:Insurance, Health; D009369:Neoplasms / Q000191:economics*; D012107:Research Design; D012189:Retrospective Studies; D014481:United States