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Methods of Analysis in Randomized Noninferiority Trials: Methodological Survey Review Protocol.
Daniel Xie1, Sameer Parpia2,3, Tyler McKechnie2,4
1Department of Integrated Biomedical Engineering and Health Sciences, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
JMIR Research Protocols
|March 13, 2026
Summary
This study reviews analysis populations in noninferiority (NI) trials. It examines intention-to-treat (ITT) versus per-protocol (PP) methods to ensure robust trial conclusions.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
Background:
- Noninferiority (NI) trials are increasingly used to compare experimental interventions against standard care.
- The choice of analysis population, such as intention-to-treat (ITT) or per-protocol (PP), significantly impacts the robustness of NI trial conclusions.
- The ITT analysis is often considered less conservative than the PP analysis in NI settings.
Purpose of the Study:
- To conduct a methodological review of analysis population sets utilized in contemporary noninferiority trials.
- To assess the prevalence and characteristics of different analysis populations in recent NI studies.
Main Methods:
- A comprehensive electronic literature search across MEDLINE, Embase, Emcare, and Cochrane CENTRAL.
- Inclusion criteria focused on noninferiority trials published in 2024.
- Primary outcome: analysis population for the primary trial analysis (ITT, PP, as-treated); Secondary outcomes: NI margin, effect estimates, confidence intervals (CIs).
- Descriptive statistics will be employed for analysis.
Main Results:
- An initial search identified 1209 studies.
- 403 noninferiority trials were deemed eligible for data extraction.
- Data extraction commenced in January 2025 and is projected to conclude in January 2026.
Conclusions:
- This methodological survey will detail the analysis populations used in the primary analysis of NI trials.
- The study aims to identify factors associated with the selection of specific analysis methods in NI trials.
Keywords:
analysisanalysis populationintention-to-treatnoninferiorityper-protocolrandomized controlled trialMore Related Videos
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