TL36: Multi-regional Trials: Design, Analysis, and Interpretation
*Susan Huyck, Merck Research Laboratories 

Keywords: MRCT, stratification, interaction tests, subgroup analysis

The purpose of this roundtable will be to discuss statistical considerations for the: 1) design (e.g. stratify yes or no?, subgroup size - how small is too small?); 2) analysis (e.g. interaction tests (which, what p-value?) or separation of subgroups?); and,

3) interpretation (e.g. when are subgroups the same, when are they different, direction vs. magnitude of effect) of multi-regional trial data.