This paper addresses the problem of deciding whether the dose response relationships between subgroups and the full population in a multi-regional trial are similar to each other. Similarity is measured in terms of the maximal deviation between the dose response curves. We consider a parametric framework and develop two powerful bootstrap tests for the similarity between the dose response curves of one subgroup and the full population, and for the similarity between the dose response curves of several subgroups and the full population. We prove the validity of the tests, investigate the finite sample properties by means of a simulation study and finally illustrate the methodology in a case study.

翻译：本文探讨了多区域试验中，亚组与总体人群之间的剂量反应关系是否具有相似性的判别问题。相似性通过剂量反应曲线间的最大偏差来衡量。在参数化框架下，我们提出了两种高效的bootstrap检验方法：一种用于检验单个亚组与总体人群的剂量反应曲线相似性，另一种用于检验多个亚组与总体人群的剂量反应曲线相似性。我们验证了检验的有效性，通过模拟研究考察了有限样本性质，并最终通过案例研究展示了该方法的实际应用。