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Session 9: Cardiovascular Outcome Trial for Safety – Alternative Approaches to Ruling Out Cardiovascular Risk
Session Chair(s)
Mat Soukup, PhD
Deputy Director, Division of Biometrics VII, OB, OTS CDER
FDA, United States
Jerald Schindler, DrPH
Chief Executive Officer
Strategic Statistics, United States
The 2008 FDA Guidance, Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes established that an excess amount of CV risk be ruled out in two stages. The objective of the first stage is to rule out a relative 80% increase in risk and the second stage objective is to rule out a 30% relative increase in CV risk. In consideration of this two-stage approach various strategies have been proposed, all of which require the use of a cardiovascular outcome trial (CVOT) at some point in the development of a new antidiabetic therapy. The session will review the background of the two-stage approach and discuss some novel approaches to address these objectives
Speaker(s)
Speaker
Jean-Marc Guettier
FDA, United States
Director, Division of Metabolism & Endocrinology Products, OND, CDER
Speaker
Joseph G. Ibrahim, PhD
Univ. of North Carolina School of Public Health, United States
Alumni Distinguished Professor of Biostatistics
Speaker
L.J. Wei, PhD
Harvard University, United States
Professor of Biostatistics
Discussant
Christy Chuang-Stein, PhD
Chuang-Stein Consulting, LLC, United States
Vice President, Head of Statistical Research and Consulting Center
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