Reference : Use of the Beta-Binomial Model for Central Statistical Monitoring of Multicenter Clin...
Scientific journals : Article
Physical, chemical, mathematical & earth Sciences : Mathematics
Human health sciences : Multidisciplinary, general & others
Use of the Beta-Binomial Model for Central Statistical Monitoring of Multicenter Clinical Trials
Desmet, L. [ISBA, Université Catholique de Louvain, Louvain-la-Neuve, Belgium]
Venet, D. [IRIDIA, Université Libre de Bruxelles, Brussels, Belgium and Breast Cancer Translational Research Lab, Institut Bordet, Université Libre de Bruxelles, Belgium]
Doffagne, E. [CluePoints S.A., Louvain-la-Neuve, Belgium]
Timmermans, Catherine mailto [Université de Liège - ULiège, Département de mathématique ; ISBA, Université Catholique de Louvain, Louvain-la-Neuve, Belgium > > > > >]
Legrand, Catherine [Université Catholique de Louvain - UCL > > > >]
Burzykowski, T. [IDDI, Louvain-la-Neuve, Belgium, I-BioStat, Hasselt University, Belgium]
Buyse, M. [I-BioStat, Hasselt University, Belgium, Biostatistics, IDDI, San Francisco, CA, United States]
Statistics in Biopharmaceutical Research
Taylor and Francis Inc.
Yes (verified by ORBi)
[en] Beta-binomial ; Central statistical monitoring ; Error detection ; Multicenter clinical trial
[en] As part of central statistical monitoring of multicenter clinical trial data, we propose a procedure based on the beta-binomial distribution for the detection of centers with atypical values for the probability of some event. The procedure makes no assumptions about the typical event proportion and uses the event counts from all centers to derive a reference model. The procedure is shown through simulations to have high sensitivity and high specificity if the contamination rate is small and the atypical event proportions are the result of some systematic shift in the underlying data-generating mechanism. © 2017 American Statistical Association.

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