Bayesian Approach for Evaluating Regional Treatment Effect in a Multiregional Global Trial

• Activity Number: 17
• Type: Topic Contributed
• Date/Time: Sunday, August 4, 2013 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Jianchang Lin*+ and Guohui Liu
• Companies: Millennium: The Takeda Oncology Company and Millennium: The Takeda Oncology Company
• Keywords: Multiregional global trial ; Bayesian ; Bridging study ; Survival analysis ; Oncology ; Clinical trials

Abstract

Currently, more and more clinical trials are conducted in more than one region within the same protocol, which is promising strategy to make valuable medicines available to patients globally with the minimum time lag. For example, a continuation arm is added into the trial to facilitate global simultaneous drug development. However, due to the potential impact of ethnic or other factors, it also arise lot of challenging issues when it comes to the global registration of a new treatment. Among them, how to assess the treatment effect for the each local region/country is one of most important topics. In this work, we will evaluate Bayesian approaches to combine the data from local extension arm and global trial to get an improved analysis of treatment effect for the local patients. The goal of such bridging can be facilitated fundamentally and naturally from Bayesian perspective since it borrow information across difference regions and ethnic factors to yield much more powerful statistical inference. A multiregional oncology trial example with survival endpoint will be illustrated for the application.