Unknown

Dataset Information

0

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

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.

SUBMITTER: Ostuzzi G 

PROVIDER: S-EPMC7214710 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

Json Xml
altmetric image

Publications

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

Ostuzzi Giovanni G   Gastaldon Chiara C   Petrini Carlo C   Godman Brian B   Barbui Corrado C  

Epidemiology and psychiatric sciences 20200506

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. ...[more]

Similar Datasets

Unknown Socio-Economic and Political Challenges of EU Member Countries: Grasping the Policy Direction of the European Semester.
| S-EPMC8503392 | biostudies-literature
Unknown Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries.
| S-EPMC3349611 | biostudies-other
Unknown Classical biological control of the African citrus psyllid Trioza erytreae, a major threat to the European citrus industry.
| S-EPMC6603031 | biostudies-literature
Unknown Circulation of pertussis and poor protection against diphtheria among middle-aged adults in 18 European countries.
| S-EPMC8128873 | biostudies-literature
Unknown A case study of polypharmacy management in nine European countries: Implications for change management and implementation.
| S-EPMC5905890 | biostudies-literature
Unknown Non-pharmacological interventions for schizophrenia-analysis of treatment guidelines and implementation in 12 Southeast European countries.
| S-EPMC8888596 | biostudies-literature
Unknown The EU(7)-PIM list: a list of potentially inappropriate medications for older people consented by experts from seven European countries.
| S-EPMC4464049 | biostudies-literature
Unknown Management of major obstetric hemorrhage prior to peripartum hysterectomy and outcomes across nine European countries.
| S-EPMC8360099 | biostudies-literature
Unknown Policy implementation for methicillin-resistant Staphylococcus aureus in seven European countries: a comparative analysis from 1999 to 2015.
| S-EPMC5533128 | biostudies-other
Unknown A pragmatic cluster randomised trial evaluating three implementation interventions.
| S-EPMC3457838 | biostudies-other