Use of the Beta-Binomial Model for Central Statistical Monitoring of Multicenter Clinical Trials. (2nd January 2017)

• Record Type: Journal Article
• Authors: Desmet, Lieven; Venet, David; Doffagne, Erik; Timmermans, Catherine; Legrand, Catherine; Burzykowski, Tomasz; Buyse, Marc
• Is Part Of: Statistics in biopharmaceutical research. Volume 9:Number 1(2017)
• Page Start: 1
• Page End: 11
• Publication Date: 2017-01-02
• Subjects: Beta-binomial -- Central statistical monitoring -- Error detection -- Multicenter clinical trial; Pharmacy -- Statistical methods -- Periodicals; Pharmaceutical biotechnology -- Statistical methods -- Periodicals; Biopharmaceutics -- Periodicals; Biometry -- Periodicals; Pharmacy -- Statistical methods; Periodicals; 615.190727
• DOI: 10.1080/19466315.2016.1164751
• Languages: English
• ISSNs: 1946-6315

Abstract

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.