Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries. (2020)

• Record Type: Journal Article
• Authors: Ostuzzi, Giovanni; Gastaldon, Chiara; Petrini, Carlo; Godman, Brian; Barbui, Corrado
• Is Part Of: Epidemiology and psychiatric sciences. Volume 29(2020)
• Publication Date: 2020
• Subjects: Antidepressants, -- psychopharmacology, -- randomised controlled trials, -- research design and methods, -- research governance; Epidemiology -- Periodicals; Mental illness -- Periodicals; Community psychiatry -- Periodicals; 362.2
• DOI: 10.1017/S2045796020000396
• Languages: English
• ISSNs: 2045-7960

Abstract

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.