New perspective and new challenges in clinical trial regulation in Italy

Abstract

Summary. Since 2004 the European Directive 2001/20/EC concerning the implementation of good clinical practice in the conduct of clinical trials on medicinal products has become operative in Italy (Decreto legislativo 24 giugno 2003, n. 211). It is therefore the intention of the Ministry of Health to obtain through an intelligent application of the recent national decree clear indications on how to conduct and to monitor transparent and useful clinical trials and to best exploit the results emerging from clinical studies in our country, both and equally from “commercial” and “non commercial” clinical studies. Using data coming from the National Register on Clinical Trials, we have observed that the absolute number of clinical research has significantly increased raising 845 interventional trials in 2008. Even if the total number of researches seems to have a positive trend and the well designed clinical trials remain the most reliable way to get unbiased information, probably we need to integrate clinical trial data with other type of clinical research, in order to better manage the post-marketing uses. Furthermore, a new pathway for “from clinical trials to the market” has to be explored through a scientific debate among the scientific community.