Cost of insurance policies for investigator-initiated cancer clinical trials in Italy

Francesco Perrone, Maurizio Marangolo, Francesco Di Costanzo, Giuseppe Colucci, Lazzaro Repetto, Marco Merlano, Sabino De Placido, Valter Torri, Giuseppe Comella, Roberto Labianca, Valerio Parisi, Ciro Gallo

Research output: Contribution to journalArticle

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 languageEnglish
Pages (from-to)373-379
Number of pages7
JournalTumori
Volume91
Issue number4
Publication statusPublished - Jul 2005

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Insurance
Italy
Research Personnel
Clinical Trials
Costs and Cost Analysis
Deductibles and Coinsurance
Neoplasms
Sample Size

Keywords

  • Good clinical practice
  • Insurance
  • Non-profit clinical trials

ASJC Scopus subject areas

  • Cancer Research

Cite this

Perrone, F., Marangolo, M., Di Costanzo, F., Colucci, G., Repetto, L., Merlano, M., ... Gallo, C. (2005). Cost of insurance policies for investigator-initiated cancer clinical trials in Italy. Tumori, 91(4), 373-379.

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 journalArticle

Perrone, F, Marangolo, M, Di Costanzo, F, Colucci, G, Repetto, L, Merlano, M, De Placido, S, Torri, V, Comella, G, Labianca, R, Parisi, V & Gallo, C 2005, 'Cost of insurance policies for investigator-initiated cancer clinical trials in Italy', Tumori, vol. 91, no. 4, pp. 373-379.
Perrone F, Marangolo M, Di Costanzo F, Colucci G, Repetto L, Merlano M et al. Cost of insurance policies for investigator-initiated cancer clinical trials in Italy. Tumori. 2005 Jul;91(4):373-379.
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. / Cost of insurance policies for investigator-initiated cancer clinical trials in Italy. In: Tumori. 2005 ; Vol. 91, No. 4. pp. 373-379.
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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.",
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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

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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

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