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Activity Number: 677
Type: Topic Contributed
Date/Time: Thursday, August 13, 2015 : 10:30 AM to 12:20 PM
Sponsor: Section on Bayesian Statistical Science
Abstract #315916
Title: Use of Modeling and Simulations to Facilitate Potential Switch from Noninferiority to Superiority
Author(s): Guoliang 'Charlie' Cao* and Wenwen Zhang
Companies: Takeda Pharmaceuticals and Takeda Pharmaceuticals
Keywords: Bayesian Statistics ; Non-inferiority ; Superiority ; Decision Making ; Modeling and Simulation
Abstract:

Cardiovascular ( CV ) outcomes studies have been requested by regulatory bodies in some therapeutic areas to rule out excessive CV safety risk. The event rate in such trials is relatively small (approximately 2-4% per year). As such, a large sample size for these trials is expected and the study may last many years. During that period, additional external information may be available. In this presentation, we will discuss how to incorporate these information via modeling and simulation for the decision making regarding potentially switching non-inferiority to superiority.


Authors who are presenting talks have a * after their name.

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