What doesn’t work with Phase IV studies? A real experience from an Ethics Committee

GRIGOLETTO, F.; Department Of Environmental Medicine And Public Health, School Of Medicine - University Of Padua & FRIGO, A. C.; Department Of Environmental Medicine And Public Health, School Of Medicine - University Of Padua
Phase IV studies are conducted in real-life conditions to expand the knowledge on the efficacy and safety of an approved drug. Carried out either in hospital or general practice setting, they can be distinguished in Phase IV trials and post-marketing surveillance studies. Limited information is available in Italy about their characteristics as the proportion of observational studies, the average size and the importance of the non-sponsored research. In order to investigate these and other features,...