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Rates and Weights: Quantifying Clinical Impact and Judgment in Benefit-risk Assessment
Program Code:
172
Date:
Monday, June 25, 2012
Time:
3:30 PM to 5:00 PM
EST
CHAIR
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Dr. Levitan has over 20 years experience in decision analysis, modeling and simulation. He specializes in benefit-risk assessment and co-leads development of the PhRMA Benefit Risk Action Team (BRAT) Framework. He received his BSc from Columbia Univ and his MD-PhD from the Univ of Pennsylvania.
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PRESENTER
(S):
Brett Hauber, RTI International, United States
Dr Irony joined FDA to implement Bayesian methods in Medical Device Trials. She was instrumental in preparing guidances on the Use of Bayesian Statistics in Medical Device Trials and Factors to Consider when Making Benefit: Risk Determinations. She leads the Decision Analysis initiative at CDRH.
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Before becoming Senior Medical Officer, he was professor and chair of clinical pharmacology and vice-rector at the Medical University of Vienna. Other positions held include President of the Vienna School of Clinical Research. His industry experience includes UK Ciba-Geigy and US Merck & Co
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Visiting Professor of Decision Science at the London School of Economics. Awarded the Frank P. Ramsey medal for "distinguished contributions to decision analysis" by the Decision Analysis Society of INFORMS.
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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.