title: Incremental costs of enrolling cancer patients in clinical trials: a population-based study.
abstract: BACKGROUND
  Payment for care provided as part of clinical research has become less predictable as a result of managed care. Because little is known at present about how entry into cancer trials affects the cost of care for cancer patients, we conducted a matched case-control comparison of the incremental medical costs attributable to participation in cancer treatment trials.
  
  
  METHODS
  Case patients were residents of Olmsted County, MN, who entered phase II or phase III cancer treatment trials at the Mayo Clinic from 1988 through 1994. Control patients were patients who did not enter trials but who were eligible on the basis of tumor registry matching and medical record review. Sixty-one matched pairs were followed for up to 5 years after the date of trial entry for case patients or from an equivalent date for control patients. Hospital, physician, and ancillary service costs were estimated from a population-based cost database developed at the Mayo Clinic.
  
  
  RESULTS
  Trial enrollees incurred modestly (no more than 10%) higher costs over various follow-up periods. The mean cumulative 5-year cost in 1995 inflation-adjusted U.S. dollars among trial enrollees after adjustment for censoring was $46424 compared with $44 133 for control patients. After 1 year, trial enrollee costs were $24645 compared with $23 964 for control patients.
  
  
  CONCLUSIONS
  This study suggests that cancer chemotherapy trials may not imply budget-breaking costs. Cancer itself is a high-cost illness. Clinical protocols may add relatively little to that cost.
authors.affiliation: Congressional Budget Office, Washington, DC, USA.
authors.forename: J L
authors.initials: JL
authors.lastname: Wagner
authors.forename: S R
authors.initials: SR
authors.lastname: Alberts
authors.forename: J A
authors.initials: JA
authors.lastname: Sloan
authors.forename: S
authors.initials: S
authors.lastname: Cha
authors.forename: J
authors.initials: J
authors.lastname: Killian
authors.forename: M J
authors.initials: MJ
authors.lastname: O'Connell
authors.forename: P
authors.initials: P
authors.lastname: Van Grevenhof
authors.forename: J
authors.initials: J
authors.lastname: Lindman
authors.forename: C G
authors.initials: CG
authors.lastname: Chute
mesh_terms: D002173:Cancer Care Facilities / Q000191:economics*; D016022:Case-Control Studies; 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; D005260:Female; D017721:Hospital Costs; D006770:Hospitals, Group Practice / Q000191:economics; D006801:Humans; D008297:Male; D016555:Matched-Pair Analysis; D008910:Minnesota; D009369:Neoplasms / Q000191:economics* / Q000628:therapy; D018579:Patient Selection; D014481:United States