Document Detail


Secondary analysis of clinical trials--a cautionary note.
MedLine Citation:
PMID:  22226000     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
John R Marler
Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Progress in cardiovascular diseases     Volume:  54     ISSN:  1873-1740     ISO Abbreviation:  Prog Cardiovasc Dis     Publication Date:    2012 Jan-Feb
Date Detail:
Created Date:  2012-01-09     Completed Date:  2012-02-23     Revised Date:  2013-05-02    
Medline Journal Info:
Nlm Unique ID:  0376442     Medline TA:  Prog Cardiovasc Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  335-7     Citation Subset:  AIM; IM    
Copyright Information:
Published by Elsevier Inc.
Affiliation:
Division of Neurology Products, CDER, US Food & Drug Administration, Silver Spring, MD 20993-0002, USA. john.marler@fda.hhs.gov
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:
Clinical Trials as Topic / ethics*,  standards
Data Interpretation, Statistical*
Humans
Selection Bias

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


Previous Document:  Approaches to data analyses of clinical trials.
Next Document:  Rudiments of subgroup analyses.