Document Detail

Exact statistical inference for group sequential trials.
MedLine Citation:
PMID:  1786325     Owner:  NLM     Status:  MEDLINE    
This paper considers clinical trials comparing two treatments with dichotomous responses where the data are examined periodically for early evidence of treatment difference. The existing group sequential methods for such trials are based on the large-sample normal approximation to the joint distribution of the estimators of treatment difference over interim analyses. We demonstrate through extensive numerical studies that, for small and even moderate-sized trials, these approximate procedures may lead to tests with supranominal size (mainly when unpooled estimators of variance are used) and confidence intervals with under-nominal coverage probability. We then study exact methods for group sequential testing, repeated interval estimation, and interval estimation following sequential testing. The new procedures can accommodate any treatment allocation rules. An example using real data is provided.
D Y Lin; L J Wei; D L DeMets
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Publication Detail:
Type:  Journal Article; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Biometrics     Volume:  47     ISSN:  0006-341X     ISO Abbreviation:  Biometrics     Publication Date:  1991 Dec 
Date Detail:
Created Date:  1992-03-20     Completed Date:  1992-03-20     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0370625     Medline TA:  Biometrics     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1399-408     Citation Subset:  IM    
Department of Biostatistics, University of Washington, Seattle 98195.
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MeSH Terms
Clinical Trials as Topic / statistics & numerical data*
Confidence Intervals
Likelihood Functions

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

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