An Extension of Likelihood Ratio Test-Based Method for Signal Detection in a Drug Class with Application to FDA's AERS Database
*Yueqin Zhao, U.S. Food and Drug Administration 

Keywords: zero-inflated Poisson, Sensitivity, False Discovery Rate

A likelihood ratio test (LRT), recently developed for the detection of signals of adverse events (AEs) for a drug of interest in the FDA Adverse Events Reporting System (FAERS) database, is extended to detect signals of AEs simultaneously for all the drugs in a drug class. This extended LRT, based on Poisson model (Ext-LRT) and zero inflated Poisson model (Ext-ZIP-LRT) are discussed. Simulation studies are performed to evaluate the performance characteristics of Ext-LRT and Ext-ZIP-LRT as well as their power and sensitivity. The proposed methods are applied to the Gadolinium drug class in FAERS database.