Non-adherence in non-inferiority trials: pitfalls and recommendations
Yin Mo, Cherry Lim, James A Watson, Nicholas J. White, Ben S. Cooper
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.
Topics & Concepts
Transparency (behavior)MedicineClinical trialOutcome (game theory)Alternative medicineResearch designComputer scienceStatisticsInternal medicinePathologyMathematicsComputer securityMathematical economicsStatistical Methods in Clinical TrialsAdvanced Causal Inference TechniquesHealth Systems, Economic Evaluations, Quality of Life