Bayesian approaches for data-mining for spontaneous adverse events
*Ram Tiwari, OTS, CDER FDA Keywords: Bayesian method, Safety Signal Detection, FDA In this presentation we will review different Bayesian methods for drug safety signal detection in large databases such as the FDA Adverse Events Reporting System (FAERS) database, which is a computerized information database designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products. The FDA uses FAERS to monitor adverse events and medication errors that might occur with these marketed products. The Bayesian methods for signal detection include Multi-Gamma Poisson Shrinker (MGPS) and Bayesian Confidence Propagating Neural Network (BCPNN), among others. We will review these methods and present two new methods; one a simplified Bayesian (sB) method and the other that uses Dirichlet process (DP) as a prior for modeling the reporting rates of drug-adverse event combinations. The performance of the proposed methods will be evaluated using a simulation study and the methods will be applied to the FAERS database.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC