Multiregional Clinical Trials for Simultaneous Global New Drug Development

This book presents a comprehensive overview on the current status of conducting MRCTs in clinical development. It first provides a high-level introduction to the context, motivation, opportunities, and challenges in simultaneous global clinical development using MRCTs. It then focuses on the design, monitoring, and analysis/interpretation of MRCTs. The book concludes with an examination of the latest research topics, such as special considerations by local health authorities, health economic evaluations, benefit-risk assessment, and medical devices.