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Activity Number: 44
Type: Contributed
Date/Time: Sunday, August 9, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #317168 View Presentation
Title: Practical Considerations for Consistency Assessment in Multiregional Clinical Trials with Oncology Examples
Author(s): Jianchang Lin* and Zhaoyang Teng and Guohui Liu and Xuedong Chi and Mingxiu Hu
Companies: Takeda Pharmaceutical International Co. and Takeda Pharmaceutical International Co. and Takeda Pharmaceutical International Co. and Takeda Pharmaceuticals and Takeda Pharmaceuticals
Keywords: MRCT ; Bayesian ; Oncology ; Clinical Trials
Abstract:

With the increasing global drug development, more and more multiregional clinical trials (MRCTs) are conducted in more than one region within the same protocol or study, which is a promising strategy to make valuable medicines available to patients globally and simultaneously with minimal registration delay. However, due to the potential impact of ethnic and/or other factors, it also poses lots of challenging issues when it comes to the global registration of a new treatment. In this work, we would focus on the challenges in study designs and analysis issues, including the systematic review of methodological approaches to assess regional differences or consistency of treatment effect and practical considerations/applications in real oncology trials/examples. Both frequent and Bayesian approaches will be discussed and compared on different endpoints (Continuous, Binary and Survival) with our recommendations. We anticipate these research work and lesson learned experience will help shape the other successful MRCTs for the globalization of drug development.


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

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