Literature DB >> 20382668

Has the European Clinical Trials Directive been a success?

L J Frewer, D Coles, K Champion, J Demotes-Mainard, N Goetbuget, K Ihrig, I Klingmann, C Kubiak, S A Lejeune, F McDonald, J Apperley.   

Abstract

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Year:  2010        PMID： 20382668     DOI： 10.1136/bmj.c1862

Source DB:  PubMed          Journal:  BMJ        ISSN： 0959-8138


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  10 in total

1.  Deciphering the EU clinical trials regulation.

Authors:  Mohamed Abou-El-Enein; Christian K Schneider
Journal:  Nat Biotechnol       Date:  2016-03       Impact factor: 54.908

2.  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.

Authors:  Markus Hartmann
Journal:  Trials       Date:  2012-04-29       Impact factor: 2.279

3.  Impact of the European clinical trials directive on prospective academic clinical trials associated with BMT.

Authors:  L J Frewer; D Coles; I A van der Lans; D Schroeder; K Champion; J F Apperley
Journal:  Bone Marrow Transplant       Date:  2010-06-07       Impact factor: 5.483

4.  A pilot test of the new Swiss regulatory procedure for categorizing clinical trials by risk: A randomized controlled trial.

Authors:  Myriam Cevallos; Stephanie Züllig; Andri Christen; Brigitte E Meier; Martin Goetz; Michael Coslovsky; Sven Trelle
Journal:  Clin Trials       Date:  2015-06-29       Impact factor: 2.486

5.  Input analysis for two public consultations on the EU Clinical Trials Regulation.

Authors:  Holger Langhof; Jonas Lander; Daniel Strech
Journal:  Health Res Policy Syst       Date:  2016-09-17

6.  Development in the number of clinical trial applications in Western Europe from 2007 to 2015: retrospective study of data from national competent authorities.

Authors:  Tilde Dombernowsky; Merete Hædersdal; Ulrik Lassen; Simon Francis Thomsen
Journal:  BMJ Open       Date:  2017-07-10       Impact factor: 2.692

7.  Methodological challenges in European ethics approvals for a genetic epidemiology study in critically ill patients: the GenOSept experience.

Authors:  Ascanio Tridente; Paul A H Holloway; Paula Hutton; Anthony C Gordon; Gary H Mills; Geraldine M Clarke; Jean-Daniel Chiche; Frank Stuber; Christopher Garrard; Charles Hinds; Julian Bion
Journal:  BMC Med Ethics       Date:  2019-05-07       Impact factor: 2.652

8.  Early results from a multi-component French public-private partnership initiative to improve participation in clinical research - CeNGEPS: a prospective before-after study.

Authors:  Régis Bordet; Marie Lang; Christelle Dieu; Nathalie Billon; Jean-Pierre Duffet
Journal:  BMC Med Res Methodol       Date:  2015-08-19       Impact factor: 4.615

9.  Factors influencing clinical trial site selection in Europe: the Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study).

Authors:  Marta Gehring; Rod S Taylor; Marie Mellody; Brigitte Casteels; Angela Piazzi; Gianfranco Gensini; Giuseppe Ambrosio
Journal:  BMJ Open       Date:  2013-11-15       Impact factor: 2.692

10.  Trends in clinical development timeframes for antiviral drugs launched in the UK, 1981-2014: a retrospective observational study.

Authors:  Derek J Ward; Edward Hammond; Luan Linden-Phillips; Andrew J Stevens
Journal:  BMJ Open       Date:  2015-11-16       Impact factor: 2.692
  10 in total

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