Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries

Ostuzzi, Giovanni and Gastaldon, Chiara and Petrini, Carlo and Godman, Brian and Barbui, Corrado (2020) Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries. Epidemiology and Psychiatric Sciences, 29 (6). e126. ISSN 2045-7960

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    Abstract

    The principle of pragmatism in clinical trials has been broadly recognised as a way to close the gap between research and practice. In this contribution, we argue that the conduct of pragmatic clinical trials in Europe may be hampered by poor implementation of current European Union's Clinical Trial Regulation No. 536/2014.