The Italian Medicines Agency (AIFA) has published the 13th National Report on Clinical Trials of Drugs in Italy, which contains data from 2013 and provides a clear and objective picture of the clinical trials in Italy, highlighting the presence of centres performing clinical trials in the field of pharmacology, the types of research conducted and the distribution of the Ethics Committees.
Despite the global economic crisis that caused a clear decrease in the number of clinical trials (CTs) as well as in the number of patients enrolled in Europe, data show that Italy has maintained in 2013 its share in the research field, with a number of 623 CTs, estimated by AIFA.
More than the 10% of the clinical trials performed in Italy is represented by phase I studies (mainly onco-hematology), while early phase studies (phase I and II) account for the 45% of the total number (compared to 43% of the last year). Data described in this annual Report also demonstrate that the most represented therapeutic areas are oncology (35%), followed by cardiovascular (8.6%), nervous system diseases (6.9%) and blood and lymphatic system (5.1%). The 70 % of the active substances have a chemistry synthesis’s origin while the remaining 30% come from organic or biotechnology production.
Considering the studies objectives, the majority of them regards safety and efficacy (538 and 522 CTs, respectively), followed by therapeutic use (phase IV or protocols of access to medicines and security follow-up: 338 CTs) and pharmacokinetics (259 CTs).
It is also remarkable that, with a market share equal to 17.2% of the pharmacological research compared to the European Union, Italy is in line with the previous years.