Non-adherence in non-inferiority trials: pitfalls and recommendations.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 32611541.
- Also identified by DOI 10.1136/bmj.m2215 and PMC identifier 7327542.
- Licence recorded as CC BY.
- The licence permits redistribution, so the abstract is shown in full and the full text is available from the publisher.
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.
Medical subject headings
- Equivalence Trials as Topic
- Intention to Treat Analysis
- Treatment Adherence and Compliance