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