Consistency of Treatment Effect across Regions in Multiregional Clinical Trials, Part 2: Monitoring, Reporting, and Interpretation

The degree of consistency of treatment effects seen across regions within a multiregional clinical trial has important implications for all stakeholders. It can affect the ability of the trial results to be interpreted by the scientific community in an unambiguous manner and can have important ramifications for regulatory decision making. This article is part of a PhRMA team’s effort to provide perspective and recommendations on this issue. A companion article from the same team focuses on relevant design considerations, while in this article the focus is on monitoring considerations specific to multiregional trials, on how the final trial results should be presented, and on thought processes that are relevant to how signals of inconsistency should be investigated and interpreted.