Published in
Cambridge University Press, Epidemiology and Psychiatric Sciences, (29), 2020
DOI: 10.1017/s2045796020000396
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Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries
Journal article published in 2020 by
Giovanni Ostuzzi 
,
Chiara Gastaldon ,
Carlo Petrini,
Brian Godman,
Corrado Barbui
,
Chiara Gastaldon ,
Carlo Petrini,
Brian Godman,
Corrado Barbui
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Abstract
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.