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. Conclusion: 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.
| Original language | English |
|---|---|
| Pages (from-to) | 373-379 |
| Number of pages | 7 |
| Journal | Tumori |
| Volume | 91 |
| Issue number | 4 |
| Publication status | Published - Jul 2005 |
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Keywords
- Good clinical practice
- Insurance
- Non-profit clinical trials
ASJC Scopus subject areas
- Cancer Research
Cite this
Cost of insurance policies for investigator-initiated cancer clinical trials in Italy. / Perrone, Francesco; Marangolo, Maurizio; Di Costanzo, Francesco; Colucci, Giuseppe; Repetto, Lazzaro; Merlano, Marco; De Placido, Sabino; Torri, Valter; Comella, Giuseppe; Labianca, Roberto; Parisi, Valerio; Gallo, Ciro.
In: Tumori, Vol. 91, No. 4, 07.2005, p. 373-379.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Cost of insurance policies for investigator-initiated cancer clinical trials in Italy
AU - Perrone, Francesco
AU - Marangolo, Maurizio
AU - Di Costanzo, Francesco
AU - Colucci, Giuseppe
AU - Repetto, Lazzaro
AU - Merlano, Marco
AU - De Placido, Sabino
AU - Torri, Valter
AU - Comella, Giuseppe
AU - Labianca, Roberto
AU - Parisi, Valerio
AU - Gallo, Ciro
PY - 2005/7
Y1 - 2005/7
N2 - 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. Conclusion: 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.
AB - 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. Conclusion: 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.
KW - Good clinical practice
KW - Insurance
KW - Non-profit clinical trials
UR - http://www.scopus.com/inward/record.url?scp=26444578216&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=26444578216&partnerID=8YFLogxK
M3 - Article
C2 - 16277110
AN - SCOPUS:26444578216
VL - 91
SP - 373
EP - 379
JO - Tumori
JF - Tumori
SN - 0300-8916
IS - 4
ER -