DIA 48th Annual Meeting
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Rates and Weights: Quantifying Clinical Impact and Judgment in Benefit-risk Assessment
Track : Track 15: Statistical Science and Quantitative Thinking
Program Code: 172
Date: Monday, June 25, 2012
Time: 3:30 PM to 5:00 PM  EST
CHAIR :
 Bennett Levitan, Janssen Research & Development, LLC, United States
PRESENTER (S):
Brett Hauber, RTI International, United States
 Telba Irony, FDA, United States
 Hans-Georg Eichler, European Medicines Agency, United Kingdom
 Lawrence Phillips, London School of Economics, United Kingdom
Description
Complex benefit-risk assessments require quantifying tradeoffs between multiple benefits and risks. This session examines an assessment for triptans in migraine and compares two different weighting methods that incorporate patient or clinical judgment.

Learning Objectives:
List the qualitative and quantitative issues considered in a complex benefit-risk assessment, with a focus on triptans for acute migraine
Describe two methods for quantitative benefit-risk assessment, stated choice preference studies and multiple-criteria decision analysis, in terms of time/expertise needed, practical considerations, value added, and ability to communicate results
Identify when these methodologies are appropriate in your organization.