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Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries
Epidemiology and Psychiatric Sciences ( IF 5.9 ) Pub Date : 2020-05-06 , DOI: 10.1017/s2045796020000396
Giovanni Ostuzzi 1 , Chiara Gastaldon 1 , Carlo Petrini 2 , Brian Godman 3, 4, 5 , Corrado Barbui 1
Affiliation  

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.

中文翻译:

欧盟临床试验法规执行不力是欧洲国家务实试验的主要威胁

临床试验中的实用主义原则已被广泛认为是缩小研究与实践差距的一种方式。在这篇文章中,我们认为在欧洲进行务实的临床试验可能会因当前欧盟第 536/2014 号临床试验条例的执行不力而受到阻碍。
更新日期:2020-05-06
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