Document Detail

Stepwise gatekeeping procedures in clinical trial applications.
MedLine Citation:
PMID:  17240656     Owner:  NLM     Status:  MEDLINE    
This paper discusses multiple testing problems in which families of null hypotheses are tested in a sequential manner and each family serves as a gatekeeper for the subsequent families. Gatekeeping testing strategies of this type arise frequently in clinical trials with multiple objectives, e.g., multiple endpoints and/or multiple dose-control comparisons. It is demonstrated in this paper that the parallel gatekeeping procedure of Dmitrienko, Offen and Westfall (2003) admits a simple stepwise representation (n null hypotheses can be tested in n steps rather than 2n steps required in the closed procedure). The stepwise representation considerably simplifies the implementation of gatekeeping procedures in practice and provides an important insight into the nature of gatekeeping inferences. The derived stepwise gatekeeping procedure is illustrated using clinical trial examples.
Alex Dmitrienko; Ajit C Tamhane; Xin Wang; Xun Chen
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural    
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:  984-91     Citation Subset:  IM    
Eli Lilly and Company, Indianapolis, IN 46285, 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*
Sample Size
Treatment Outcome*
Grant Support
1 R01 HL082725-01A1/HL/NHLBI NIH HHS
Erratum In:
Biom J. 2006 Dec;48(6):1041

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

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