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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.
Acknowledgments
The authors thank two reviewers for making suggestions that substantially improved the article.
Funding
The authors gratefully acknowledge financial support from the Walloon Government under the BioWin framework (Consortium agreement nr. 6741). Partial support for this research (Catherine Legrand and Tomasz Burzykowski) was provided by the IAP Research Network P7/06 of the Belgian State (Belgian Science Policy).