Non-adherence in non-inferiority trials: pitfalls and recommendations. (1st July 2020)

• Record Type: Journal Article
• Authors: Mo, Yin; Lim, Cherry; Watson, James A; White, Nicholas J; Cooper, Ben S
• Is Part Of: BMJ. Volume 370(2020)
• Publication Date: 2020-07-01
• Subjects: Medicine -- Periodicals; Medicine -- Periodicals; Medicine; Periodicals; 610
• DOI: 10.1136/bmj.m2215
• Languages: English
• ISSNs: 0007-1447

Abstract

Abstract : Non-adherence in non-inferiority trials can affect treatment effect estimates and often increases the chance of claiming non-inferiority under the standard intention-to-treat analysis. This article discusses the implications of different patterns of non-adherence in non-inferiority trials and offers practical recommendations for trial design, alternative analysis strategies, and outcome reporting to reduce bias in treatment estimates and improve transparency in reporting.