Report Clinical Trials of Drugs in Italy 2011

Number of pages: 271
Date: 15/12/2011

Available in English the 10th National Report Clinical Trials of Drugs in Italy containing information relating to the period January 1, 2006 - December 31, 2010 processed by the National Monitoring Centre for Clinical Trials (OsSC).
This year, the analysis on Phase I studies, objectives of the clinical trials, studies on orphan drugs and substantial amendments have become integrating parts of the Clinical trials section; instead, specific analyses have been made on female population and patients incapable of validly submitting their consent.
Following the creation of the Registry on Observational Studies (RSO), a specific section concerns this kind of studies.
The Ethics committees section contains specific analyses on time necessary to issue the single opinion (for coordinating centres) and the acceptance/refusal of the single opinion (for satellite centres), for the period January 1, 2007 - December 31, 2010.