Non-Inferiority Trials: A Systematic Review on Methodological Quality and Reporting Standards.

ABSTRACT:

Background

Non-inferiority (NI) trials require unique trial design and methods, which pose challenges in their interpretation and applicability, risking introduction of inferior therapies in clinical practice. With the abundance of novel therapies, NI trials are increasing in publication. Prior studies found inadequate quality of reporting of NI studies, but were limited to certain specialties/journals, lacked NI margin evaluation, and did not examine temporal changes in quality. We conducted a systematic review without restriction to journal type, journal impact factor, disease state or intervention to evaluate the quality of NI trials, including a comprehensive risk of bias assessment and comparison of quality over time.

Methodology

We searched PubMed and Cochrane Library

SUBMITTER: Sengul A 

PROVIDER: S-EPMC11436551 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature