Design and Analysis of Multiregional Clinical Trials in Evaluation of Medical Devices: Some Points to Consider from a Regional Regulatory Perspective

• Activity Number: 113
• Type: Topic Contributed
• Date/Time: Monday, August 1, 2016 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Yunling Xu* and Nelson LU
• Companies: FDA/CDRH and FDA/CDRH
• Keywords: MRCT ; Medical devices ; Reginal regulatory decision

Abstract

Within the context of statistical design and analysis of multiregional clinical trials for medical devices, some issues encountered in regional regulatory review will be illustrated with examples. Accordingly, statistical approaches to inform regional regulatory decision will be discussed.