Understanding noninferiority trials
Open accessAbstract
Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.
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ITT and completer analyses are recommended when assessing noninferiority, primarily because ITT analyses can bias results toward equivalence.
“ITT and completer analyses are recommended when assessing noninferiority, primarily because ITT analyses can bias results toward equivalence.22”
From Telehealth Versus In-Person Acceptance and Commitment Therapy for Chronic Pain: A Randomized Noninferiority Trial. (2017) · cites this paper as Hahn, 2012
In “Choosing the analysis population,” the paper says ITT analysis can bias noninferiority results toward equivalence and recommends conducting both ITT and per-protocol analyses. It does not specifically recommend a completer analysis; its per-protocol population also excludes patients with major protocol violations. (LLM, conf=0.84)
Experimental — accuracy not yet measuredNoninferiority was claimed only if results were consistent between ITT and completer samples.
“We claimed noninferiority only if results were consistent between ITT and completer samples.22”
From Telehealth Versus In-Person Acceptance and Commitment Therapy for Chronic Pain: A Randomized Noninferiority Trial. (2017) · cites this paper as Hahn, 2012
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Reporting of Noninferiority and Equivalence Randomized Trials: An Extension of the CONSORT Statement
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- Authors
- Hahn, S.
- Affiliations
- Seoul National University (KR)
- Corresponding author
- Hahn, Seokyung
- ORCID
- Hahn, Seokyung
- Venue
- Korean Journal of Pediatrics
- Publisher
- Korean Pediatric Society
- Published
- 2012
- Volume
- 55
- Issue
- 11
- Pages
- 403
- ISSN
- 1738-1061 (ISSN-L)
- 2092-7258
- PMC
- PMC3510268
- OpenAlex
- W2113954950
- Cited by
- 160
- References
- 1
- Citations by year
- 2026: 7 · 2025: 11 · 2024: 20 · 2023: 22 · 2022: 9 · 2021: 18 · 2020: 19 · 2019: 18 · 2018: 11 · 2017: 12 · 2016: 10 · 2015: 3
- FWCI
- 0.92
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- Locations
- Korean Journal of Pediatrics (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Keywords
- non-inferiority, active control, trial design, trial interpretation, pediatric clinical trials
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