Assessing Consistency of Treatment Effect in Multiregional Clinical Trials

• Activity Number: 345
• Type: Topic Contributed
• Date/Time: Tuesday, August 11, 2015 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Bin Zhang* and Zhaoyang Teng and Jing Wang
• Companies: Millennium Pharmaceutical, Inc. and Takeda Pharmaceutical International Co. and Gilead Sciences
• Keywords: MRCT ; consistency ; clinical trials ; multi-reginal

Abstract

One of the challenges to multi-regional clinical trials (MRCT) is how to utilize the data obtained from other regions to help make local approval decisions. In addition to the global efficacy, the evidence of consistency in treatment effects between the local region and the entire trial is usually required for regional approval. In recent years, a number of statistical models and consistency criteria have been proposed. However, there is no specific regional requirement being broadly accepted. Moreover, most of the consistency requirements were proposed for continuous endpoint; they may not be suitable for other endpoints, e.g. binary and survival. Thus, in this research, we assess different consistency requirements for different measurements of different endpoints (continuous, binary and survival endpoints). Take binary endpoint as an example, different consistency requirements will be proposed and evaluated for different measurements of treatment effect, i.e. risk difference, relative risk and odds ratio. Sample size requirement to guarantee certain probability of regional approval for each region will be also discussed in detail.