Defining Regions in Multiregional Clinical Trials: An Analytical Approach to Considering Impact of Intrinsic and Extrinsic Factors

Conclusion:
Using a checklist to identify intrinsic/extrinsic factors that might lead to differences in treatment effect allows one to scientifically define more meaningful regions from the identified factors, which will help with estimating the relative treatment outcome as well as exploring appropriate regional sample size.

Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Tanaka, Y., Buchanan, A., Lipsius, S., Ibia, E. O., Rabbia, M., Binkowitz, B. Tags: Global Perspectives Source Type: research