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.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC