Document Detail

Interim monitoring of bivariate responses using repeated confidence intervals.
MedLine Citation:
PMID:  7913675     Owner:  NLM     Status:  MEDLINE    
A method for interim monitoring is described for bivariate response data arising in clinical trials. This procedure centers on a sequence of rectangular joint confidence regions obtained by inverting the hypothesis testing-confidence interval relationship when the testing procedure is governed by a bivariate group sequential design described by Cook and Farewell [4]. The advantage of this type of design over other possible multivariate sequential designs is that the marginal analyses are maintained throughout the trial. This approach proves to be particularly advantageous for active control trials in which a region of therapeutic equivalence is specified for two responses related to efficacy. Two examples illustrate the design and analysis aspects of this approach. The procedure is presented in the context of normally distributed responses; however, adaptations to handle bivariate binary and bivariate failure time data are indicated. Generalizations of this procedure to handle multivariate response data are straightforward.
R J Cook
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Controlled clinical trials     Volume:  15     ISSN:  0197-2456     ISO Abbreviation:  Control Clin Trials     Publication Date:  1994 Jun 
Date Detail:
Created Date:  1994-08-24     Completed Date:  1994-08-24     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8006242     Medline TA:  Control Clin Trials     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  187-200     Citation Subset:  IM    
Department of Statistics and Actuarial Science, University of Waterloo, Canada.
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MeSH Terms
Administration, Inhalation
Adrenergic beta-Agonists / administration & dosage
Analysis of Variance
Arthritis, Rheumatoid / drug therapy
Asthma / drug therapy
Clinical Trials as Topic / statistics & numerical data*
Confidence Intervals*
Cyclosporine / administration & dosage,  adverse effects
Dose-Response Relationship, Drug
Double-Blind Method
Models, Statistical
Quality of Life
Therapeutic Equivalency
Grant Support
Reg. No./Substance:
0/Adrenergic beta-Agonists; 59865-13-3/Cyclosporine

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

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