Literature DB >> 19205659

Submission of clinical studies to ethics committees or clinical trials registers: the authors' point of view.

Daniel Pehboeck1, Matthias Hohlrieder, Volker Wenzel, Arnulf Benzer.   

Abstract

To evaluate the satisfaction of clinical scientists when submitting study drafts to an ethics committee/clinical trials register (CLINICALTRIALS, EUDRACT, ISRCTN) we conducted an online survey of 240 authors publishing in anesthesia/critical care medicine (A) or in major general medical (M) journals from January to December 2007. No statistical difference between groups A and M was seen with regard to the number of studies submitted to ethics committees or registered in various clinical trials registers. On a visual analogue scale (VAS -10 to +10), the subjective evaluation of the effort required to submit a study draft to an ethics committee or enter it in a clinical trials register produced almost only negative grades in both groups. The mean different perceptions ranged from -3.5 to -0.1 in group A and from -4.4 to -0.2 (except for +0.1 and 1.9 in 2 subgroups) in group M. The authors in both groups gave a positive score to the better transparency in scientific research resulting from introduction of the clinical trials registers (+2.4 in group A, +4.8 in group M). The results of our study indicate widespread author dissatisfaction when submitting a clinical trial to ethics committees or clinical trials registers.

Mesh:

Year:  2009        PMID: 19205659     DOI: 10.1007/s00134-009-1434-3

Source DB:  PubMed          Journal:  Intensive Care Med        ISSN: 0342-4642            Impact factor:   17.440


  9 in total

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Authors:  David S Wald
Journal:  BMJ       Date:  2004-07-31

2.  Clinical trial registration: a statement from the International Committee of Medical Journal Editors.

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3.  Randomized clinical trials: slow death by a thousand unnecessary policies?

Authors:  Salim Yusuf
Journal:  CMAJ       Date:  2004-10-12       Impact factor: 8.262

4.  Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

Authors: 
Journal:  Med Etika Bioet       Date:  2002 Spring-Summer

5.  Reversing the decline of academic medicine in Europe.

Authors:  Desmond J Sheridan
Journal:  Lancet       Date:  2006-05-20       Impact factor: 79.321

6.  [The 12th German Drug Law (AMG) amendment: an obstruction for non-commercial clinical trials?].

Authors:  S Schwarz; L Frölich; J-P Striebel; M G Hennerici
Journal:  Dtsch Med Wochenschr       Date:  2007-01-19       Impact factor: 0.628

7.  Does the European clinical trials directive really improve clinical trial approval time?

Authors:  Hiddo J Lambers Heerspink; Daniela Dobre; Hans L Hillege; Diederick E Grobbee; Dick de Zeeuw
Journal:  Br J Clin Pharmacol       Date:  2008-06-28       Impact factor: 4.335

8.  Researchers see a need for speed in EU trial approvals.

Authors:  Daniel Cressey
Journal:  Nat Med       Date:  2008-08       Impact factor: 53.440

Review 9.  Time to publication for results of clinical trials.

Authors:  S Hopewell; M Clarke; L Stewart; J Tierney
Journal:  Cochrane Database Syst Rev       Date:  2007-04-18
  9 in total
  4 in total

1.  Should European Independent Ethics Committees be dismantled?

Authors:  Olivier Chassany
Journal:  Intensive Care Med       Date:  2009-02-12       Impact factor: 17.440

2.  [Publication performances of university clinics for anesthesiology: Germany, Austria and Switzerland from 2001 to 2010].

Authors:  G Putzer; J Ausserer; V Wenzel; D Pehböck; T Widmann; K Lindner; P Hamm; P Paal
Journal:  Anaesthesist       Date:  2014-04-10       Impact factor: 1.041

Review 3.  Year in review in Intensive Care Medicine 2009. Part III: mechanical ventilation, acute lung injury and respiratory distress syndrome, pediatrics, ethics, and miscellanea.

Authors:  Massimo Antonelli; Elie Azoulay; Marc Bonten; Jean Chastre; Giuseppe Citerio; Giorgio Conti; Daniel De Backer; François Lemaire; Herwig Gerlach; Goran Hedenstierna; Michael Joannidis; Duncan Macrae; Jordi Mancebo; Salvatore M Maggiore; Alexandre Mebazaa; Jean-Charles Preiser; Jerôme Pugin; Jan Wernerman; Haibo Zhang
Journal:  Intensive Care Med       Date:  2010-02-23       Impact factor: 17.440

4.  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

  4 in total

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