Contemporary Clinical Trials 33 (2012) 573
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Letter to the Editor Insurance and clinical trials Keywords: Clinical trials Insurance coverage Risk management Liability Research ethics committees Institutional review boards
The need for the insurance and the indemnification is a recent development in the EU regulations to protect the subjects participant in clinical trials. The Clinical Trial Directive 2001/ 20/EC states that the liability of the investigator or sponsor for possible injury or death of the trial subject has to be covered by insurance or indemnity [1]. For over a year, Italian investigators and Research Ethics Committees (RECs) have been facing a new difficulty due to a Ministerial Decree, which entered into force on March 2010 that obliges the investigator or the sponsor of an interventional clinical trial to provide specific, very expensive, insurance coverage. Without this specific insurance coverage, drafted in compliance with the requirements set forth in the Decree, the RECs cannot approve a trial. Also, ‘a posteriori’, the results of a trial that had been erroneously approved by the REC, without insurance coverage, will not be taken into account for the purpose of evaluating the marketing authorization application [2]. In our opinion, there could be possible negative consequences for the patients involved in the study and for those who could benefit from the trial results rather than for the sponsor and the investigator! This legislation is causing problems especially for the “noncommercial” trials promoted by clinical investigators of academic or clinical research institutions for the improvement of clinical practice (for example, studies comparing current treatments in need of more evidence) or for rare diseases. The paradox is that many of these studies would result in a very minimal risk or no greater than of those of current clinical settings and which do not require insurance. Equally, risks are not greater than taking a medication administered off-label, outside of a clinical trial. We think that it is not correct that clinical trials' insurance requirements consider, as required by the Italian Decree, only the number of patients and a general classification of risk (with the exception of clinical trials in pediatrics, gene therapy, cellular therapy and radio-pharmaceutics). This regulation make no distinction between Phase II or III trials (often of new drugs where the risks are unknown) versus Phase IV trials (where data on efficacy and safety are available). 1551-7144/$ – see front matter © 2012 Elsevier Inc. All rights reserved. doi:10.1016/j.cct.2012.02.015
Even the Concept Paper put out for public consultation for the revision of the Directive 2001/20/EC states that the clinical trials have very different risk-profiles, that depend on a wide range of factors: particularly, the extent of knowledge and prior experience with the investigational treatment, the intervention compared to normal clinical practice and the subject population involved [3]. The scarce funds available for clinical research should not be wasted and the costs for insurance should be limited to take into account the risk profiles of the clinical trials. Higher costs of insurance should be requested/levied only for those that have more risks than the current clinical practice for the same case. Conflicts of interest The authors have not received any specific grant for this manuscript. References [1] 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, 1.05.2001. Available at: http://www.eortc.be/Services/Doc/clinical-EUdirective-04-April-01.pdf (Accessed July 15 2011) [2] Ministerial Decree 14 July 2009, Minimum requirements for insurance policies which safeguard participants to clinical trials of medicinal products, Gazzetta Ufficiale della Repubblica Italiana, Serie generale 213, 14.9.2009. Available at: http://ricerca-clinica.agenziafarmaco.it/sites/ default/files/files_wysiwyg/files/Normativa/MD_14_July_2009_English. pdf (Accessed July 15 2011) [3] European Commission — Health and Consumers Directorate-General. Revision of the ‘Clinical Trial Directive’ 2001/20/EC. Concept Paper submitted for public consultation. p. 12. Available at: http://ec.europa.eu/health/ files/clinicaltrials/concept_paper_02-2011.pdf (Accessed July 15, 2011).
Roberta Minacori⁎ Dario Sacchini Marina Cicerone Antonio G. Spagnolo Institute of Bioethics, “Agostino Gemelli” School of MedicineUniversità Cattolica del Sacro Cuore, Rome, Italy ⁎Corresponding author at: Institute of Bioethics, “Agostino Gemelli” School of Medicine-Università Cattolica del Sacro Cuore, Largo Francesco Vito, 1; Zip Code:00168 Rome, Italy. Tel.: + 39 06 30154205; fax: +39 06 3051149. E-mail address:
[email protected] (R. Minacori). 11 February 2012
