Are all quantitative postmarketing signal detection methods equal? Performance characteristics of logistic regression and Multi‐item Gamma Poisson Shrinker

The detection of safety signals with medicines is an essential activity to protect public health. Despite widespread acceptance, it is unclear whether recently applied statistical algorithms provide enhanced performance characteristics when compared with traditional systems. Novartis has adopted a novel system for automated signal detection on the basis of disproportionality methods within a safety data mining application (Empirica™ Signal System [ESS]). ESS uses two algorithms for routine analyses: empirical Bayes Multi‐item Gamma Poisson Shrinker and logistic regression (LR).

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