Use of the Beta-Binomial Model for Central Statistical Monitoring of Multicenter Clinical Trials

[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.

Disciplines :

Mathematics
Human health sciences: Multidisciplinary, general & others

Author, co-author :

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 ; 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

Language :

English

Title :

Use of the Beta-Binomial Model for Central Statistical Monitoring of Multicenter Clinical Trials

Publication date :

2017

Journal title :

Statistics in Biopharmaceutical Research

eISSN :

1946-6315

Publisher :

Taylor and Francis Inc.

Volume :

Issue :

Pages :

1-11

Peer reviewed :

Peer Reviewed verified by ORBi

Additional URL :

https://www.tandfonline.com/doi/abs/10.1080/19466315.2016.1164751

Available on ORBi :

since 07 February 2019

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