Cited by 205Statistical Methods in Clinical TrialsMeta-analysis and systematic reviewsPharmaceutical studies and practices

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Methodology of superiority vs. equivalence trials and non-inferiority trials

Christensen, Erik·2007·Journal of Hepatology

DOI 10.1016/j.jhep.2007.02.015

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Abstract

The randomized clinical trial (RCT) is generally accepted as the best method of comparing effects of therapies. Most often the aim of an RCT is to show that a new therapy is superior to an established therapy or placebo, i.e. they are planned and performed as superiority trials. Sometimes the aim of an RCT is just to show that a new therapy is not superior but equivalent to or not inferior to an established therapy, i.e. they are planned and performed as equivalence trials or non-inferiority trials. Since the types of trials have different aims, they differ significantly in various methodological aspects. The awareness of the methodological differences is generally quite limited. This paper reviews the methodology of these types of trials with special reference to differences in respect to planning, performance, analysis and reporting of the trial. In this context the relevant basal statistical concepts are reviewed. Some of the important points are illustrated by examples.

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Authors: Christensen, E.
Affiliations: Bispebjerg Hospital (DK)
Corresponding author: Christensen, Erik
ORCID: Christensen, Erik
Venue: Journal of Hepatology
Publisher: Elsevier BV
Published: 2007-05
Volume: 46
Issue: 5
Pages: 947-954
ISSN: 0168-8278 (ISSN-L)
DOI: 10.1016/j.jhep.2007.02.015
OpenAlex: W2018758420
Cited by: 205
References: 29
Citations by year: 2026: 9 · 2025: 9 · 2024: 16 · 2023: 19 · 2022: 12 · 2021: 6 · 2020: 14 · 2019: 13 · 2018: 14 · 2017: 15 · 2016: 8 · 2015: 6 · 2014: 12 · 2013: 11 · 2012: 5
FWCI: 8.08
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Journal of Hepatology (publishedVersion)
PubMed (publishedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords: superiority trials, equivalence trials, randomized controlled trials, trial design, statistical analysis, trial reporting, statistical concepts, treatment comparison
MeSH terms: Animals, Clinical Protocols, Clinical Trials as Topic, Data Interpretation, Statistical, Humans, Patient Compliance, Research Design, Therapeutic Equivalency, Confidence Intervals, Randomized Controlled Trials as Topic, Sample Size, Risk Assessment

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Methodology of superiority vs. equivalence trials and non-inferiority trials

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