Document Detail

A cautionary note on design implications when the primary analysis is a stratified analysis of a binary endpoint.
MedLine Citation:
PMID:  17240655     Owner:  NLM     Status:  MEDLINE    
When the primary analysis is a stratified analysis of a binary endpoint, the commonly used CMH procedure could produce results that are quite different from those obtained by ignoring the stratification factor altogether. This means that when designing a trial with a primary endpoint that is binary, it is important that one keep in mind how the data will be analyzed. Only when design and analysis are considered in tandem will the study possess the desired properties. The discussion in this paper is illustrated by a hypothetical example, which nevertheless resembles the findings from a confirmatory trial involving the evaluation of a biologic for severe sepsis.
Christy Chuang-Stein
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Biometrical journal. Biometrische Zeitschrift     Volume:  48     ISSN:  0323-3847     ISO Abbreviation:  Biom J     Publication Date:  2006 Dec 
Date Detail:
Created Date:  2007-01-23     Completed Date:  2007-02-22     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7708048     Medline TA:  Biom J     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  978-83     Citation Subset:  IM    
Pfizer Global Research and Development, Ann Arbor, Michigan 48105, USA.
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MeSH Terms
Biometry / methods*
Computer Simulation
Controlled Clinical Trials as Topic / methods*
Data Interpretation, Statistical*
Logistic Models*
Models, Statistical
Outcome Assessment (Health Care) / methods*
Research Design*
Sample Size
Treatment Outcome*

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

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