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

par Desmet, L.;Venet, David ;Doffagne, Erik;Timmermans, Catherine;Legrand, Catherine;Burzykowski, Tomasz;Buyse, Marc
Référence Statistics in Biopharmaceutical Research, 9, 1, page (1-11)
Publication Publié, 2017-01

Article révisé par les pairs

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Résumé :

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.