Evaluating Noninferiority in Clinical Trials with a Hierarchical End Point
Abstract
AbstractThe win ratio is a method for analyzing a clinical hierarchy of outcomes. It is most commonly applied to randomized clinical trials to evaluate the superiority of an intervention versus the standard of care. Once an intervention is approved, a noninferiority trial may be used to assess whether or not an alternative intervention is as effective. The authors explain how to select an appropriate noninferiority margin in terms of the win ratio, while emphasizing the importance of translating it into familiar metrics (e.g., rate ratios, differences in means) for easier interpretation. This framework is illustrated with a worked example of a hypothetical trial. The authors provide practical guidance on how the win ratio could be effectively used in future noninferiority trials.
Fields of Study & Subjects
Statistical Methods in Clinical Trials
Statistical Methods and Bayesian Inference
Advanced Causal Inference Techniques
Publication details
- Journal / source
- NEJM Evidence
- Publisher
- Massachusetts Medical Society
- Volume
- 5
- Issue
- 3
- Pages
- EVIDctw2500029–EVIDctw2500029
- Publication date
- 24 February 2026
- Language
- EN