Larger effect sizes in nonrandomized studies are associated with higher rates of EMA licensing approval
The aim of this study was to evaluate how often the European Medicines Agency (EMA) has authorized drugs based on nonrandomized studies and whether there is an association between treatment effects and EMA preference for further testing in randomized clinical trials (RCTs).
Source: Journal of Clinical Epidemiology - Category: Epidemiology Authors: Benjamin Djulbegovic, Paul Glasziou, Farina A. Klocksieben, Tea Reljic, Magali VanDenBergh, Rahul Mhaskar, John P.A. Ioannidis, Iain Chalmers Tags: Review Source Type: research