Homogeneity assessment for pivotal medical device clinical studies. Issue 5 (3rd September 2019)

• Record Type: Journal Article
• Authors: Yan, Xu; Ahn, Chul; Chu, Jianxiong; Dong, Li Ming; Li, Heng; Li, Xuefeng; Lu, Hong; Lu, Nelson; Mukhi, Vandana; Nair, Rajesh; Tiwari, Ram; Xu, Yunling; Yue, Lilly Q.
• Is Part Of: Journal of biopharmaceutical statistics. Volume 29:Issue 5(2019)
• Page Start: 749
• Page End: 759
• Publication Date: 2019-09-03
• Subjects: Medical device -- homogeneity assessment -- poolability -- clinical study; Pharmacy -- Statistical methods -- Periodicals; Drugs -- Testing -- Statistical methods -- Periodicals; Biometry -- Periodicals; Biopharmaceutics -- Periodicals; Pharmacokinetics -- Periodicals; 615.19
• DOI: 10.1080/10543406.2019.1657131
• Languages: English
• ISSNs: 1054-3406

Abstract

ABSTRACT: 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.