Statistical Issues in Multiregional Clinical Trials

• Activity Number: 427
• Type: Contributed
• Date/Time: Tuesday, August 6, 2013 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Suvajit Samanta*+
• Companies: Merck Research Laboratory
• Keywords: Multiregional trial ; Sample size ; Consistent trend

Abstract

Multiregional clinical trials (MRCTs) which are conducted in multiple regions using a common protocol present great opportunities in terms of making valuable medicines available to patients globally approximately at the same time and removing the necessity of conducting multiple large-scale confirmatory clinical studies in individual regions. However, the interpretation of multiregional clinical trials can be challenging as heterogeneity resulting from differences in ethnicity, genetic factors, culture, and clinical practice can potentially have an impact on the observed treatment efficacy and safety in different regions. Several methods have been proposed to find consistent trend in treatment effect across regions. In this presentation we will compare these methods. Then we try to extend some of the methods to find consistency under complex scenario.