Information de reference pour ce titreAccession Number: | 00005407-201110120-00028.
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Author: | Krumholz, Harlan M. MD, SM; Ross, Joseph S. MD, MHS
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Institution: | Author Affiliations: Section of Cardiovascular Medicine and the Robert Wood Johnson Clinical Scholars Program (Dr Krumholz), and Section of General Medicine (Dr Ross), Department of Internal Medicine, Yale University School of Medicine; Section of Health Policy and Administration, Yale School of Public Health, and the Center for Outcomes Research and Evaluation (Dr Krumholz), Yale-New Haven Hospital, New Haven, Connecticut.
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Title: | |
Source: | JAMA. 306(14):1593-1594, October 12, 2011.
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Author Keywords: | Clinical Trials as Topic; Data Interpretation, Statistical; Decision Making; Decision Support Techniques; Ethics, Research; Patient Safety; Product Surveillance, Postmarketing; Statistics as Topic.
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References: | 1. Eyding D, Lelgemann M, Grouven U, et al. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ. 2010;341c4737.
2. Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med. 2009;6(9):e1000144.
3. Marciniak TA. Memorandum: Cardiovascular events in RECORD, NDA 21-071/S035. FDA briefing document, advisory committee meeting for NDA 21071 Avandia (rosiglitazone maleate) table. June 14, 2010; http://www.fda.gov/AdvisoryCommi...- ouverture dans une nouvelle fenêtre. Accessed September 7, 2011
4. Ross JS, Madigan D, Konstam MA, Egilman DS, Krumholz HM. Persistence of cardiovascular risk after rofecoxib discontinuation. Arch Intern Med. 2010;170(22):2035-2036.
5. Lyman GH, Kuderer NM. The strengths and limitations of meta-analyses based on aggregate data. BMC Med Res Methodol. 2005;514.
6. Kesselheim AS, Avorn J. The role of litigation in defining drug risks. JAMA. 2007;297(3):308-311.
7. Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM. Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance. Arch Intern Med. 2009;169(21):1976-1985.
8. Winslow R. Medtronic funds Yale safety study. Wall Street Journal. August 2, 2011. http://online.wsj.com/article/SB...- ouverture dans une nouvelle fenêtre. Accessed September 7, 2011
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Language: | English.
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Document Type: | Commentary.
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Journal Subset: | Clinical Medicine.
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ISSN: | 0098-7484
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NLM Journal Code: | 7501160
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DOI Number: | https://dx.doi.org/10.1001/jama....- ouverture dans une nouvelle fenêtre
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Annotation(s) | |