Document Detail


Continuously monitored stopping boundary methodologies: the issues of sensitivity, association and trial suspension.
MedLine Citation:
PMID:  9304764     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Thall et al. consider a continuous monitoring strategy for multiple discrete outcomes to determine whether a trial should terminate early. We evaluate important issues raised in the application of a continuous monitoring strategy for multiple outcomes. Specifically, we evaluate: (i) the sensitivity of such a methodology to small perturbations in the stopping boundaries; (ii) the need to employ accrual buffers when a trial approaches a stopping boundary-a large buffer implying that temporary suspension is unwarranted; and (iii) the role of association among the multiple outcomes of interest. Simulation studies demonstrate that the methodology is sensitive to small perturbations in the stopping boundaries, that the size of an accrual buffer can vary widely over the course of a trial, and that the extent of association among multiple outcomes plays a large role in determining the stopping properties of a trial. We illustrate these issues using the HLA non-identical donor bone marrow transplant trial, with two discrete outcomes.
Authors:
E N Lazaridis; R Gonin
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Statistics in medicine     Volume:  16     ISSN:  0277-6715     ISO Abbreviation:  Stat Med     Publication Date:  1997 Sep 
Date Detail:
Created Date:  1997-11-20     Completed Date:  1997-11-20     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  1925-41     Citation Subset:  IM    
Affiliation:
Indiana University, Division of Biostatistics, Indianapolis 46202-5200, USA.
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MeSH Terms
Descriptor/Qualifier:
Bayes Theorem*
Clinical Trials, Phase II as Topic / statistics & numerical data*
Humans
Models, Statistical
Research Design*
Sample Size
Sensitivity and Specificity
Treatment Outcome

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


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