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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/24156

Title: Use of the Beta-Binomial Model for Central Statistical Monitoring of Multicenter Clinical Trials
Authors: Desmet, Lieven
Venet, David
Doffagne, Erik
Timmermans, Catherine
Legrand, Catherine
Burzykowski, Tomasz
Buyse, Marc
Issue Date: 2017
Abstract: 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.
Notes: [Desmet, Lieven; Timmermans, Catherine; Legrand, Catherine] Catholic Univ Louvain, ISBA, Louvain La Neuve, Belgium. [Venet, David] Univ Libre Bruxelles, IRIDIA, Brussels, Belgium. [Venet, David] Univ Libre Bruxelles, Inst Bordet, Breast Canc Translat Res Lab, Brussels, Belgium. [Doffagne, Erik] CluePoints SA, Louvain La Neuve, Belgium. [Timmermans, Catherine] Univ Liege, Dept Math, Liege, Belgium. [Burzykowski, Tomasz] IDDI, Louvain La Neuve, Belgium. [Burzykowski, Tomasz; Buyse, Marc] Hasselt Univ, I BioStat, Hasselt, Belgium. [Buyse, Marc] IDDI, Biostat, San Francisco, CA USA.
URI: http://hdl.handle.net/1942/24156
DOI: 10.1080/19466315.2016.1164751
ISI #: 000397258400001
ISSN: 1946-6315
Category: A1
Type: Journal Contribution
Appears in Collections: Research publications

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