| Secondary analysis of clinical trials--a cautionary note. | |
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MedLine Citation:
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PMID: 22226000 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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There is concern in published reports and reviews that patients are being harmed or denied effective treatment by the use of questionable results from secondary analyses of data from clinical trials. A well-reported secondary analysis must make clear to the reader the uncertainty of the result--so clear, in fact, that it should be an obvious part of the conclusions that implementation should await confirmation as the primary outcome in an adequately powered trial. Those who write, review and publish these reports have a responsibility to ensure that reports accurately describe the sources of uncertainty, explain complex methods and their weaknesses with clarity, and convince readers to require better evidence before changing their practice. |
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Authors:
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John R Marler |
Publication Detail:
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Type: Journal Article; Review |
Journal Detail:
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Title: Progress in cardiovascular diseases Volume: 54 ISSN: 1873-1740 ISO Abbreviation: Prog Cardiovasc Dis Publication Date: 2012 Jan-Feb |
Date Detail:
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Created Date: 2012-01-09 Completed Date: 2012-02-23 Revised Date: 2013-05-02 |
Medline Journal Info:
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Nlm Unique ID: 0376442 Medline TA: Prog Cardiovasc Dis Country: United States |
Other Details:
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Languages: eng Pagination: 335-7 Citation Subset: AIM; IM |
Copyright Information:
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Published by Elsevier Inc. |
Affiliation:
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Division of Neurology Products, CDER, US Food & Drug Administration, Silver Spring, MD 20993-0002, USA. john.marler@fda.hhs.gov |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Clinical Trials as Topic
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ethics*,
standards Data Interpretation, Statistical* Humans Selection Bias |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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