Point-to-Consider of Design Considerations on Consistency of Treatment Effect Across Regions in Multiregional Clinical Trials (MRCT)

• Activity Number: 350
• Type: Contributed
• Date/Time: Tuesday, August 5, 2014 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Huei Wang*+ and Kefei Zhou and Jenny Song
• Companies: Amgen and Amgen and Amgen
• Keywords: Multiregional clinical trials ; Consistency of treatment effect across regions ; MRCT

Abstract

To accelerate new drug development, clinical trial strategy has expanded to a global level with participation simultaneously from multiple geographical regions under the same study protocol. The possible benefits of this strategy are obvious but the challenges and issues with this strategy are many, including trial or data quality assurance, objective of consistency assessment, consistency criteria, sample size consideration, consideration of predefined regions, multiplicity issues, stratification by regions, statistical methods for design and analysis ( to evaluate consistency of treatment effect across regions), difficulty in interpretation of regional differences, and the region specific assessments and acceptability by the local regulatory authorities. In addition, an important challenge we are facing now is the lack of harmonization of regulatory guidance on MRCTs from ICH and EMA. In this poster, the point-to-consider of design consideration on consistency of treatment effect across regions in MRCT and the current regulatory guidelines in MRCT are presented and the possible solutions and recommendation to deal with such MRCT design challenges and issues are also presented.