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

Ostuzzi, Giovanni and Gastaldon, Chiara and Petrini, Carlo and Godman, Brian and Barbui, Corrado (2020) Poor implementation of the EU clinical trial regulation is a major threat for pragmatic trials in European countries. Epidemiology and Psychiatric Sciences, 29 (6). e126. ISSN 2045-7960

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    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.

    • Item type:Article
      ID code:72330
      Dates:
      Date
      Event
      6 May 2020
      Published
      10 April 2020
      Accepted
      Keywords:Italian medicine agency, clinical trials, clinical trial regulations, Pharmacy and materia medica, Pharmacology, Toxicology and Pharmaceutics(all)
      Subjects:Medicine > Pharmacy and materia medica
      Department:Faculty of Science > Strathclyde Institute of Pharmacy and Biomedical Sciences
      Depositing user: Pure Administrator
      Date deposited:07 May 2020 15:49
      Last modified:21 Jan 2021 11:56
      URI:https://strathprints.strath.ac.uk/id/eprint/72330
    CORE (COnnecting REpositories)