Document Detail


Submission of clinical studies to ethics committees or clinical trials registers: the authors' point of view.
MedLine Citation:
PMID:  19205659     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Daniel Pehboeck; Matthias Hohlrieder; Volker Wenzel; Arnulf Benzer
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Publication Detail:
Type:  Journal Article     Date:  2009-02-11
Journal Detail:
Title:  Intensive care medicine     Volume:  35     ISSN:  1432-1238     ISO Abbreviation:  Intensive Care Med     Publication Date:  2009 Apr 
Date Detail:
Created Date:  2009-03-18     Completed Date:  2009-07-13     Revised Date:  2009-08-07    
Medline Journal Info:
Nlm Unique ID:  7704851     Medline TA:  Intensive Care Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  713-6     Citation Subset:  IM    
Affiliation:
Department of Anesthesia and Intensive Care Medicine, Medical University of Innsbruck, Anichstrasse 35, 6020, Innsbruck, Austria.
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MeSH Terms
Descriptor/Qualifier:
Clinical Trials as Topic*
Ethics Committees*
Humans
Publications / standards
Questionnaires
Registries*
Writing*
Comments/Corrections
Comment In:
Intensive Care Med. 2009 Apr;35(4):579-81   [PMID:  19212755 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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