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A CASE STUDY USING THE FRAMEWORK SUPPORTED BY QUANTATATIVE METHODS FOR BENEFIT/RISK ASSESSMENT
Session Chair(s)
Deborah Ashby, PhD, MSc
Professor of Medical Statistics and Clinical Trials
Imperial College London, United Kingdom
We apply the BRAT framework to a case study assessing the Benefit/Risk of Tysabri for the treatment of Multiple Sclerosis. Two quantitative methods, the NNT and Multi-Criteria Decision Analysis are compared; followed by a regulatory perspective.
Speaker(s)
Panel Discussion
Christoph Dierig
Bayer AG, Germany
Expert Statistician
Panel Discussion
Richard Nixon, PhD, MSc
Novartis Pharma AG, Switzerland
Expert Modeler
Panel Discussion
Andrew Thomson, PhD, MA, MS
European Medicines Agency, Netherlands
Statistician, Methodology Taskforce
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