Document Detail

An efficient sequential design of clinical trials.
MedLine Citation:
PMID:  23275685     Owner:  NLM     Status:  Publisher    
We propose an efficient group sequential monitoring rule for clinical trials. At each interim analysis both efficacy and futility are evaluated through a specified loss structure together with the predicted power. The proposed design is robust to a wide range of priors, and achieves the specified power with a saving of sample size compared to existing adaptive designs. A method is also proposed to obtain a reduced-bias estimator of treatment difference for the proposed design. The new approaches hold great potential for efficiently selecting a more effective treatment in comparative trials. Operating characteristics are evaluated and compared with other group sequential designs in empirical studies. An example is provided to illustrate the application of the method.
Yi Cheng; Yu Shen
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Publication Detail:
Journal Detail:
Title:  Journal of statistical planning and inference     Volume:  143     ISSN:  0378-3758     ISO Abbreviation:  J Stat Plan Inference     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2012-12-31     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101250629     Medline TA:  J Stat Plan Inference     Country:  -    
Other Details:
Languages:  ENG     Pagination:  283-295     Citation Subset:  -    
Department of Mathematical Sciences, Indiana University, South Bend, IN 46634.
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