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 journalEditorial

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 languageEnglish
Article numbere126
JournalEpidemiology and Psychiatric Sciences
DOIs
Publication statusAccepted/In press - 2020
Externally publishedYes

Keywords

  • Antidepressants
  • psychopharmacology
  • randomised controlled trials
  • research design and methods
  • research governance

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