Non-adherence in non-inferiority trials: pitfalls and recommendations

作者：Yin Mo, Cherry Lim, James A Watson, Nicholas John White, Ben Symons Cooper · 发表于：BMJ · 年份：2020 · DOI：10.1136/bmj.m2215 · 被引用次数：70 · 研究领域：Statistical Methods in Clinical Trials、Advanced Causal Inference Techniques、Health Systems, Economic Evaluations, Quality of Life

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.