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

Research output: Contribution to journalArticle

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
Number of pages3
JournalEpidemiology and Psychiatric Sciences
Volume29
Issue number6
DOIs
Publication statusPublished - 6 May 2020

Keywords

  • Italian medicine agency
  • clinical trials
  • clinical trial regulations

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