Abstract:
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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.
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