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

^*Corresponding author for this work

Research output: Contribution to journal › Editorial

3 Citations (Scopus)

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
DOIs	https://doi.org/10.1017/S2045796020000396
Publication status	Accepted/In press - 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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title = "Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries",

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.",

keywords = "Antidepressants, psychopharmacology, randomised controlled trials, research design and methods, research governance",

author = "Giovanni Ostuzzi and Chiara Gastaldon and Carlo Petrini and Brian Godman and Corrado Barbui",

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year = "2020",

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journal = "Epidemiology and Psychiatric Sciences",

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AU - Ostuzzi, Giovanni

AU - Gastaldon, Chiara

AU - Petrini, Carlo

AU - Godman, Brian

AU - Barbui, Corrado

PY - 2020

Y1 - 2020

N2 - 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.

AB - 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.

KW - Antidepressants

KW - psychopharmacology

KW - randomised controlled trials

KW - research design and methods

KW - research governance

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DO - 10.1017/S2045796020000396

M3 - Editorial

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AN - SCOPUS:85084327179

SN - 2045-7960

JO - Epidemiology and Psychiatric Sciences

JF - Epidemiology and Psychiatric Sciences

M1 - e126

ER -

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

Abstract

Keywords

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