TL27: Challenges on Design and Analysis of Multi-regional Clinical Trials
*Weining Z Robieson, Abbvie 


Tremendous research has been conducted in the Multi-Regional Clinical Trial (MRCT) area collaboratively by stakeholders including industry, health authorities, and academia. These collaborative efforts have achieved great understanding of these issues and, at the same time, revealed many new challenges. Because of differences in expectations, objectives and concerns for MRCTs, different assumptions and statistical methods are recommended to address these challenges by stakeholders.