Document Detail

Modification of sample size in group sequential clinical trials.
MedLine Citation:
PMID:  11315017     Owner:  NLM     Status:  MEDLINE    
In group sequential clinical trials, sample size reestimation can be a complicated issue when it allows for change of sample size to be influenced by an observed sample path. Our simulation studies show that increasing sample size based on an interim estimate of the treatment difference can substantially inflate the probability of type I error in most practical situations. A new group sequential test procedure is developed by modifying the weights used in the traditional repeated significance two-sample mean test. The new test has the type I error probability preserved at the target level and can provide a substantial gain in power with the increase of sample size. Generalization of the new procedure is discussed.
L Cui; H M Hung; S J Wang
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Biometrics     Volume:  55     ISSN:  0006-341X     ISO Abbreviation:  Biometrics     Publication Date:  1999 Sep 
Date Detail:
Created Date:  2001-04-20     Completed Date:  2001-08-16     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0370625     Medline TA:  Biometrics     Country:  United States    
Other Details:
Languages:  eng     Pagination:  853-7     Citation Subset:  IM    
Division of Biometrics I, OB/CDER, Food and Drug Administration, Rockville, Maryland 20852, USA.
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MeSH Terms
Clinical Trials as Topic / statistics & numerical data*
Sample Size
Grant Support

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

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