Regulatory and Statistical Issues in Multiregional Trials: Case Studies

• Activity Number: 394
• Type: Topic Contributed
• Date/Time: Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Daphne T.Y. Lin*+ and Greg Soon and Wen Zeng
• Companies: FDA and CDER/FDA and FDA
• Keywords: Multi-Regional Clinical Trials ; Infectious Disease

Abstract

With globalization of drug development, it has been more common to see clinical trials conducted in multiple regions. Many regulatory and statistical issues have been identified in trial design, assessment of regional consistency, etc. In this talk, we will discuss several new drug applications in infectious disease areas which are often composed of several multi-regional trials. In several situations, consistent treatment effects across region were not observed, the critical issue is the applicability of non-US data for US drug approval. We will examine case studies in details and explore possible reasons for the consistency or lack of consistency across regions in treatment responses and effect sizes. How these findings will either support the use of non-US data, and how the limitations in these findings will restrict and even prohibit the use of non-US data will also be discussed.