ICH E17 Guideline 3. GLOSSARY Consistency of treatment effect : A lack of clinically relevant differences between treatment effects in different regions or subpopulations of an MRCT Multi-Regional Clinical Trial, MRCT: A clinical trial conducted in more than one region under a single protocol. Region: A geographical region, country or regulatory region Regulatory Region: A region comprised of countries for which a common set of regulatory requirements ap- plies for drug approval (e.g., EU). Pooled regions:
Pooling some geographical regions, countries or regulatory regions at the planning stage, if subjects in those regions are thought to be similar enough with respect to intrinsic and/or extrinsic factors relevant to the disease and/or drug under study. Pooled subpopulations: Pooling a subset of the subjects from a particular region with similarly defined subsets from other regions whose members share one or more intrinsic or extrinsic factors im- portant for the drug development programme at the planning stage. Pooled subpopula- tions is assumed as ethnicity-related subgroup particular important in the MRCT setting. 26