| A cautionary note on design implications when the primary analysis is a stratified analysis of a binary endpoint. | |
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MedLine Citation:
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PMID: 17240655 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Christy Chuang-Stein |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Biometrical journal. Biometrische Zeitschrift Volume: 48 ISSN: 0323-3847 ISO Abbreviation: Biom J Publication Date: 2006 Dec |
Date Detail:
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Created Date: 2007-01-23 Completed Date: 2007-02-22 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 7708048 Medline TA: Biom J Country: Germany |
Other Details:
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Languages: eng Pagination: 978-83 Citation Subset: IM |
Affiliation:
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Pfizer Global Research and Development, Ann Arbor, Michigan 48105, USA. christy.j.chuang-stein@pfizer.com |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Algorithms 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* |
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