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

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...

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Autores principales: Ostuzzi, Giovanni, Gastaldon, Chiara, Petrini, Carlo, Godman, Brian, Barbui, Corrado
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2020
Materias:
Epidemiology for Behavioural Neurosciences
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214710/
https://www.ncbi.nlm.nih.gov/pubmed/32370820
http://dx.doi.org/10.1017/S2045796020000396
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author Ostuzzi, Giovanni
Gastaldon, Chiara
Petrini, Carlo
Godman, Brian
Barbui, Corrado
author_facet Ostuzzi, Giovanni
Gastaldon, Chiara
Petrini, Carlo
Godman, Brian
Barbui, Corrado
author_sort Ostuzzi, Giovanni
collection PubMed
description 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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spelling pubmed-72147102020-05-18 Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries Ostuzzi, Giovanni Gastaldon, Chiara Petrini, Carlo Godman, Brian Barbui, Corrado Epidemiol Psychiatr Sci Epidemiology for Behavioural Neurosciences 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. Cambridge University Press 2020-05-06 /pmc/articles/PMC7214710/ /pubmed/32370820 http://dx.doi.org/10.1017/S2045796020000396 Text en © The Author(s) 2020 http://creativecommons.org/licenses/by/4.0/ http://creativecommons.org/licenses/by/4.0/This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Epidemiology for Behavioural Neurosciences
Ostuzzi, Giovanni
Gastaldon, Chiara
Petrini, Carlo
Godman, Brian
Barbui, Corrado
Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries
title Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries
title_full Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries
title_fullStr Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries
title_full_unstemmed Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries
title_short Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries
title_sort poor implementation of the eu clinical trial regulation is a major threat for pragmatic trials in european countries
topic Epidemiology for Behavioural Neurosciences
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7214710/
https://www.ncbi.nlm.nih.gov/pubmed/32370820
http://dx.doi.org/10.1017/S2045796020000396
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