Statistical Challenges and Issues Related to Multiregion Trials

• Activity Number: 584
• Type: Contributed
• Date/Time: Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Sibabrata Banerjee*+ and Lucy Shneyer
• Companies: Merck & Co., Inc. and Merck & Co., Inc.
• Keywords: Multiregion Trial ; Sample-Size estimation ; Consistency

Abstract

By Multiregion or Multinational Trial, we mean a trial conducted in multiple regions using a common protocol. The advantage of having a Multregion Trial is to get a concurrent approval in many regions which translates to saving lost time in terms of approval and marketing. This can turn out to be favorable to both the countries and the sponsors. The countries would not have to wait through the lag time to have the drug available. The sponsors would profit from simultaneous launching of the new drug in all the markets. Despite these advantages, there are many issues and challenges related to Multiregion Clinical Trials. In this study we discuss the statistical aspects related to some of them. Then we try to recommend solutions for the common problems discussed.