Direttiva Europea 2001/20/EC sulla sperimentazione clinica: implicazioni sulla ricerca clinica in Italia

Abstract

[ The European Directive 2001/20/EC on clinical trials in Italy] The European Directive 2001/20/EC legally ensured the implementation of the principles of good clinical practice in clinical trials on medicinal products in Europe. The Directive establishes, specific provisions regarding clinical trials conduction in all Member States, including multicenter trials on human subject involving medicinal products and harmonizes the practice of Independent Ethics Committees (IEC) and administrative provisions. In Italy, the European Directive was implemented by the Legislative Decree 211/2003 that considers three subsequent phases in the activation procedure of multicenter clinical trials: first, the clinical trial application submission to the IEC of both the coordinating and the participating centres as well as the administrative agreement submission to the Competent Authority of participating centres; second, the issuance of the “single” opinion by the IEC of the coordinating centre and, in case of positive opinion, the acceptance or refusal by the IEC of each participating centre; third, in case of acceptance, the trial contracts signature between the coordinating and each participating centre. Moreover, the European Directive defines the time required for issuing of opinion by the IEC. However, the high variability of documentation “centre-specific” required by independent ethics committee (IEC) plays a critical role in the time required for activation of participating centres of multicenter clinical trials. The harmonization of IECs practice in Italy and the reduction of the total number of IECs are the first step to facilitate multicenter clinical trials. Similar efforts should be made to standardize administrative procedures concerning the approval of clinical trials.