Cost of insurance policies for investigator-initiated cancer clinical trials in Italy.
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.
Perrone
Francesco
F
National Cancer Institute, Naples (APRIC-CTPG), Italy. fr.perrone@agora.it
Marangolo
Maurizio
M
Di Costanzo
Francesco
F
Colucci
Giuseppe
G
Repettos
Lazzaro
L
Merlano
Marco
M
De Placido
Sabino
S
Torri
Valter
V
Comella
Giuseppe
G
Labianca
Roberto
R
Parisi
Valerio
V
Gallo
Ciro
C
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*