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Activity Number: 137 - New Advances in Statistical Methods for Complex Data
Type: Invited
Date/Time: Monday, July 31, 2017 : 10:30 AM to 12:20 PM
Sponsor: International Chinese Statistical Association
Abstract #321998 View Presentation
Title: Signal Detection from Large Drug Safety Databases
Author(s): Ram Tiwari*
Companies: FDA/CDER/OT/OB
Keywords: Likelihood Ratio Test ; Familywise error rate ; False discovery rate ; Passive surveillance ; Active surveillance ; Reporting rate

The statistical methods used for data-mining or signal detection of drug-adverse event combinations from large drug safety databases such as FDA's Adverse Event Reporting System (FAERS), consisting of spontaneous reports on adverse events for post-market drugs are called passive surveillance methods. On the other hand, the statistical signal detection methods for longitudinal data, as the data accrues in time, are called active surveillance methods. A review of the most commonly used passive surveillance statistical methods, along with the likelihood ratio test (LRT) based methods, will be discussed in detail.

Authors who are presenting talks have a * after their name.

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