title: Cost of insurance policies for investigator-initiated cancer clinical trials in Italy.
abstract: BACKGROUND
  Clinical trials with non-profit promoters are frequently performed in oncology and represent a highly valuable source of information.
  
  
  METHODS
  To describe the costs of insurance policies and their determinants, data were collected from 12 Italian non-profit promoters of cancer trials. The cost of policies was expressed as per-patient premium.
  
  
  RESULTS
  Sixty-two quotations issued by only two companies were collected, relative to 44 trials proposed for quotation between December 1998 and February 2003. Only the date of quotation was significantly associated with the cost (P = 0.0003) of quotations by Company A for policies with a deductible, with cost increasing over time. Date of quotation (P = 0.0002), sample size (P = 0.008) and number of study arms (P = 0.02) were independently associated with the cost of no-deductible policies quoted by Company A. Only the number of study arms was significantly associated with cost (P = 0.0001) in no-deductible policies quoted by Company B.
  
  
  CONCLUSIONS
  There is insufficient competition among companies for insurance of cancer trials with non-profit promoters. Many variables that affect the trial risk profile from a clinical perspective are not associated with insurance cost. Date of quotation is among the strongest determinants of the cost, which has sharply increased over time. This trend may become a serious problem for non-profit promoters of cancer clinical trials.
authors.affiliation: National Cancer Institute, Naples (APRIC-CTPG), Italy. fr.perrone@agora.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
authors.forename: Maurizio
authors.initials: M
authors.lastname: Marangolo
authors.forename: Francesco
authors.initials: F
authors.lastname: Di Costanzo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Colucci
authors.forename: Lazzaro
authors.initials: L
authors.lastname: Repettos
authors.forename: Marco
authors.initials: M
authors.lastname: Merlano
authors.forename: Sabino
authors.initials: S
authors.lastname: De Placido
authors.forename: Valter
authors.initials: V
authors.lastname: Torri
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Comella
authors.forename: Roberto
authors.initials: R
authors.lastname: Labianca
authors.forename: Valerio
authors.initials: V
authors.lastname: Parisi
authors.forename: Ciro
authors.initials: C
authors.lastname: Gallo
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D007348:Insurance, Health / Q000191:economics*; D007558:Italy; D009369:Neoplasms / Q000191:economics* / Q000628:therapy; D012108:Research Personnel; D035842:Research Subjects / Q000191:economics*