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An Interactive Course on Likelihood Ratio Test-based Method for Signal Detection
Session Chair(s)
Ram Tiwari, PHD, MS
Head of Statistical Methodology
Bristol Myres Squibb , United States
This workshop will provide an overview of the likelihood ratio test-based signal detection method for FDA’s Adverse Event Reporting System (AERS) database. It will also include a demonstration via the presentation of the likelihood ratio test (LRT) tool to certain drugs or adverse events.
**Due to workshop format, seating will be limited and will be available on a first come, first served basis.
The Boston Convention and Exhibition Center (BCEC) has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.
Learning Objective : Identify data-mining in drug safety database by learning some commonly used methods for disproportionality analysis in drug safety database, a new method that controls false positive and has good sensitivity and power; Recognize how the LRT can be used as an accompanying tool.
Speaker(s)
Facilitator
Lan Huang, PHD
FDA, United States
Mathematical Statistician, Office of Biostatistics, OTS, CDER
Facilitator
Ted J Guo, PHD
FDA, United States
Mathematical Statistician, Office of Biostatistics, OTS, CDER