A question that routinely arises in medical device clinical studies is the homogeneity across demographic subgroups, geographical regions, or investigational sites of the enrolled patients in terms of treatment effects or outcome variables. The main objective of this paper is to discuss statistical concepts and methods for the assessment of such homogeneity and to provide the practitioner a statistical framework and points to consider in conducting homogeneity assessment. Demographic subgroups, geographical regions, and investigational sites are discussed separately as each has its unique issues. Specific considerations are also given to randomized controlled trials, non-randomized comparative studies, and single-arm studies. We point out that judicious use of statistical methods, in conjunction with sound clinical judgment, is essential in handling the issue of homogeneity of treatment effect in medical device clinical studies.

在医疗器械临床研究中经常出现的一个问题是，就治疗效果或结果变量而言，入组患者的人口统计学亚组，地理区域或研究地点之间的同质性。本文的主要目的是讨论用于评估此类同质性的统计概念和方法，并为从业人员提供进行同质性评估时应考虑的统计框架和要点。人口分组，地理区域和研究地点将分别讨论，因为每个都有其独特的问题。还特别考虑了随机对照试验，非随机比较研究和单组研究。我们指出，明智地使用统计方法以及合理的临床判断，