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

Giovanni Ostuzzi; Chiara Gastaldon; Carlo Petrini; Brian Godman; Corrado Barbui

doi:10.1017/S2045796020000396

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

Giovanni Ostuzzi
, Chiara Gastaldon
, Carlo Petrini
, Brian Godman
, Corrado Barbui

University of Verona
Istituto Superiore di Sanita
University of Strathclyde
University of Liverpool
Karolinska Institutet

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

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.

Original language	English
Article number	e126
Journal	Epidemiology and Psychiatric Sciences
Volume	29
DOIs	https://doi.org/10.1017/S2045796020000396
State	Published - 6 May 2020
Externally published	Yes

Keywords

Antidepressants
psychopharmacology
randomised controlled trials
research design and methods
research governance

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10.1017/S2045796020000396

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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.",

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AU - Barbui, Corrado

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KW - psychopharmacology

KW - randomised controlled trials

KW - research design and methods

KW - research governance

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

Abstract

Keywords

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