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

Intensive Care Medicine

Volumn 35, Issue 4, 2009, Pages 713-716

  Pehboeck, Daniel ^a   Hohlrieder, Matthias ^a   Wenzel, Volker ^a   Benzer, Arnulf ^a  

^a INNSBRUCK MEDICAL UNIVERSITY   (Austria)

Author keywords

European union; Organization and administration ethical review; Standards clinical trials; Standards medicine; Trends public opinion

Indexed keywords

ARTICLE; AUTHOR; CLINICAL RESEARCH; CONTROLLED STUDY; INTENSIVE CARE; PROFESSIONAL STANDARD; PUBLISHING; QUESTIONNAIRE; SCIENTIFIC LITERATURE; SCIENTIST; SCORING SYSTEM; VISUAL ANALOG SCALE;

CLINICAL TRIALS AS TOPIC; ETHICS COMMITTEES; HUMANS; PUBLICATIONS; QUESTIONNAIRES; REGISTRIES; WRITING;

EID: 62949145416     PISSN: 03424642     EISSN: 14321238     Source Type: Journal    
DOI: 10.1007/s00134-009-1434-3     Document Type: Article

References (9)

1. S Hopewell M Clarke L Stewart J Tierney 2007 Time to publication for results of clinical trials Cochrane Database Syst Rev 18 MR000011
2. European Parliament. Directive 2001/20/EC 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. Official Journal of the European Communities, Brussels, 1 May 2001
3. DS Wald 2004 Bureaucracy of ethics applications Br Med J 329 282 284
4. S Yusuf 2004 Randomized clinical trials: slow death by a thousand unnecessary policies? Can Med Assoc J 171 889 892
5. C De Angelis JM Drazen FA Frizelle C Haug J Hoey R Horton S Kotzin C Laine A Marusic AJ Overbeke TV Schroeder HC Sox MB Van Der Weyden International Committee of Medical Journal Editors 2004 Clinical trial registration. A statement from the International Committee of Medical Journal Editors Ann Intern Med 141 477 478
6. S Schwarz L Frölich JP Striebel MG Hennerici 2007 The 12th German Drug Law (AMG) amendment: an obstruction for non-commercial clinical trials? Dtsch Med Wochenschr 132 108 112
7. DJ Sheridan 2006 Reversing the decline of academic medicine in Europe Lancet 367 1698 1701
8. HJ Lambers Heerspink D Dobre HL Hillege DE Grobbee D de Zeeuw 2008 Does the European Clinical Trials Directive really improve clinical trial approval time? Br J Clin Pharmacol 66 546 550
9. D Cressey 2008 Researchers see a need for speed in EU trial approvals Nat Med 14 794