Insurance for independent cancer trials

According to the ICH-GCP [1Go] and a recent EU directive [2Go], promoters of multicentre clinical trials should provide an insurance policy for each study, covering damages eventually occurring to enrolled patients because of trial procedures. The cost of policies may be lowered in case a franchise is applied, that is a threshold of indemnity under which the promoter will pay directly for the eventual damage induced to the patient; but the latter is seldom accepted by non-profit promoters because of unforeseeable financial risk.

We collected data on 62 quotations from 12 non-profit Italian promoters of cancer trials [Associazione per la Promozione della Ricerca Clinica—Clinical Trials Promoting Group (APRIC-CTPG); Istituto Oncologico Romagnolo (IOR); Gruppo Oncologico Italiano per la Ricerca Clinica (GOIRC); Gruppo Oncologico Italia Meridionale (GOIM); Gruppo Italiano di Oncologia Geriatrica (GIOGER); Gruppo Oncologico Nord-Ovest (GONO); Dipartimento di Endocrinologia e Oncologia Molecolare e Clinica, University Federico II of Naples (DEOMC); Istituto di Ricerche Farmacologiche Mario Negri Institute of Milan (IRFMN); Southern Italy Cooperative Oncology Group (SICOG); Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente (GISCAD); and Società Italiana di Chirurgia Oncologica (SICO)]. Only two insurance companies were interested in issuing such a type of policy without franchise: company A (14 quotations) and company B (22 quotations). With company A, the median cost per patient was 85.50 euros ({euro}) (range 18.00–196.00). A backwards stepwise multiple linear regression analysis revealed that the date of quotation (P=0.0002), sample size (P=0.008) and number of study arms (P=0.02) were independently predictive of cost, and accounted for 88% of its variability. Cost was higher for more recent quotations, smaller sample size and phase II rather than III trials. Among the 22 quotations issued by company B, the median cost per patient was 80.00 {euro} (range 30.00–165.00). Multivariate analysis revealed that only the number of study arms was significantly predictive of cost (P=0.0001), which was higher with a lower number of study arms, and this variable accounted for 57% of the variability of the cost. Among the quotations from company B, the date of quotation was associated with cost only in the univariate analysis. In Figure 1, the association of cost with date of quotation is graphically displayed for both company A (filled circles, solid line) and company B (open squares, dashed line). These data show that the cost of policies is sharply increasing over time, and this trend can become a serious problem for non-profit promoters of cancer clinical trials. In addition, it seems that there is insufficient competition among companies for insurance of cancer trials with non-profit promoters.



View larger version (12K):
[in this window]
[in a new window]
 
Figure 1. Correlation between cost of insurance and date of quotation for company A (filled circles, solid line) and company B (open squares, dashed line).

 

F. Perrone1,*, M. Marangolo2, F. Di Costanzo3, G. Colucci4, L. Repetto5, M. Merlano6, S. De Placido7, V. Torri8, G. Comella9, R. Labianca10, V. Parisi11 and C. Gallo12

1 National Cancer Institute, Naples (APRIC-CTPG); 2 Medical Oncology, Ravenna (IOR); 3 Medical Oncology, Florence (GOIRC); 4 Oncologic Institute, Bari (GOIM); 5 Medical Oncology INRCA, Rome (GIOGer); 6 Medical Oncology, Cuneo (GONO); 7 Department of Molecular and Clinical Endocrinology and Oncology, University Federico II of Naples (Oncotech); 8 Mario Negri Institute, Milan (IRFMN); 9 National Cancer Institute, Naples (SICOG); 10 Medical Oncology, Bergamo (GISCAD); 11 National Cancer Institute, Naples (SICO) 12 Department of Medicine and Public Health, Second University of Naples, Naples (APRIC-CTPG), Italy

* Email: fr.perrone{at}agora.it

Acknowledgements

The authors thank Fiorella Romano for assistance during data collection and data management. The Clinical Trials Unit of the National Cancer Institute of Naples is partially supported by AIRC (Associazione Italiana per la Ricerca sul Cancro) and CTPG (Clinical Trials Promoting Group). This work was presented as a poster at the Fifth National Congress of Italian Society of Medical Oncology (AIOM).

References

1. Good Clinical Practice. Also referred to as: ICH E6: Good Clinical Practice: Consolidated Guideline, CPMP/ICH/135/95. Legislative Basis Directive 75/318/EEC as amended, July 1996, entered into force in January (1997). [On-line]. http://pharmacos.eudra.org/F2/eudralex/vol-3/pdfs-en/3cc1aen.pdf (27 July 2004, date last accessed).

2. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the Approximation of the Laws, Regulations and Administrative Provisions of the Member States Relating to the Implementation of Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for Human Use. Official Journal of the European Communities, 1.5.2001, L 121/34-44.





This Article
Full Text (PDF)
E-letters: Submit a response
Alert me when this article is cited
Alert me when E-letters are posted
Alert me if a correction is posted
Services
Email this article to a friend
Similar articles in this journal
Similar articles in PubMed
Alert me to new issues of the journal
Add to My Personal Archive
Download to citation manager
Disclaimer
Request Permissions
Google Scholar
Articles by Perrone, F.
Articles by Gallo, C.
PubMed
PubMed Citation
Articles by Perrone, F.
Articles by Gallo, C.