An Interactive Course on Likelihood Ratio Test-based Method for Signal Detection
Track
:
Track 14: Clinical Safety and Pharmacovigilance
Program Code:
356
Date:
Wednesday, June 26, 2013
Time:
1:45 PM to 3:15 PM
EST
Location:
157C
CHAIR
:
Ram Tiwari, PhD (SCHAGY), Associate Director, Office of Biostatistics, OTS, CDER, FDA, United States
His current research interests include developing frequentist and Bayesian methods in clinical trials and pre-and-post market drug safety evaluation.
SPEAKER
(S):
Ted J. Guo, PhD (SPKAGY), Mathematical Statistician, Office of Biostatistics, OTS, CDER, FDA, United States
His recent focus is the development of a software solution for the evaluation of drug-induced liver injury named eDISH. He is creating a software tool for the evaluation of adverse events reported to FDA’s AERS database using the Likelihood Ratio Test named LRT.
Lan Huang, PhD (SPKAGY), Mathematical Statistician, Office of Biostatistics, OTS, CDER, FDA, United States
She has published papers on missing data, Bayesian statistical modeling, survival cure modeling, spatial cluster detections, modeling cancer trends and evaluating drug safety. Her current research interests include biomarker qualifications, cancer surveillance, and drug safety surveillance.
Description
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.