Document Detail

Continuously monitored stopping boundary methodologies: the issues of sensitivity, association and trial suspension.
MedLine Citation:
PMID:  9304764     Owner:  NLM     Status:  MEDLINE    
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.
E N Lazaridis; R Gonin
Related Documents :
19501784 - Do calorie-controlled portion sizes of snacks reduce energy intake?
21345624 - Alcohol consumption and depressive symptoms over time: a longitudinal study of patients...
21538654 - Validation of a 4-item negative symptom assessment (nsa-4): a short, practical clinical...
10278764 - Predictors of benefit from art, movement, and poetry therapy: a pilot study.
22827194 - The effect of topical indomethacin on subjective symptoms in chronic corneal edema.
21795404 - Responsiveness of goal attainment scaling in comparison to two standardized measures in...
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    
Indiana University, Division of Biostatistics, Indianapolis 46202-5200, USA.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Bayes Theorem*
Clinical Trials, Phase II as Topic / statistics & numerical data*
Models, Statistical
Research Design*
Sample Size
Sensitivity and Specificity
Treatment Outcome

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

Previous Document:  Design for sample size re-estimation with interim data for double-blind clinical trials with binary ...
Next Document:  A graphical assessment of the potential impact of losses to follow-up on the validity of study resul...