Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries.
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ABSTRACT:
SUBMITTER: Ostuzzi G
PROVIDER: S-EPMC7214710 | biostudies-literature | 2020 May
REPOSITORIES: biostudies-literature
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Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries.
Ostuzzi Giovanni G Gastaldon Chiara C Petrini Carlo C Godman Brian B Barbui Corrado C
Epidemiology and psychiatric sciences 20200506
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. ...[more]
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