Quality of Reporting of Noninferiority and Equivalence Randomized Trials
Abstract
Context Noninferiority and equivalence trials aim to show that the experimental treatment is not clinically worse than (noninferior) or clinically similar to (equivalent) a control active treatment. These study objectives imply particular planning and analysis. Objective To assess the methodologic quality of reports of randomized controlled trials of noninferiority and equivalence. Design We searched MEDLINE and the Cochrane Central Register of Controlled Trials for reports of randomized controlled trials of noninferiority and equivalence hypotheses published between January 1, 2003, and December 31, 2004. Main outcome measures Data extracted by use of a standardized form involved assessment of choice of noninferiority or equivalence margins, sample size calculation, sets of patients analyzed, method of statistical testing and reporting results, and conclusions. Results A total of 162 reports were included in the analysis (116 reports of noninferiority and 46 of equivalence). The margin defining noninferiority or equivalence was described in most reports (156 [96.3%]), with justification of the margin in only 33 (20.4%). Almost one quarter of the reports (35 [21.6%]) did not describe a sample size calculation, and an additional 11 (6.8%) did not take into account a prespecified noninferiority or equivalence margin. Less than half of the reports (69 [42.6%]) described both an intent-to-treat (ITT; all randomized patients are included in the analysis) or modified ITT (patients…
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There is much confusion in the literature surrounding equivalence/noninferiority studies.
“There is much confusion in the literature surrounding equivalence/noninferiority studies.”
From Understanding Equivalence and Noninferiority Testing (2011) · cites this paper as [14]
There has been a recent increase in the use of equivalence/noninferiority testing.
“There has been a recent increase in the use of equivalence/ noninferiority testing.”
From Understanding Equivalence and Noninferiority Testing (2011) · cites this paper as [14]
About 80% of the reports did not justify their choice of equivalence margin, and 28% did not take into consideration the margin in the sample size calculation.
“For example, about 80% of the reports did not justify their choice of equivalence margin, and 28% did not take into consideration the margin in the sample size calculation.”
From Understanding Equivalence and Noninferiority Testing (2011) · cites this paper as [14]
Le Henanff identified 162 reports of equivalence/noninferiority trials published in 2003 and 2004.
“Le Henanff 14 identified 162 reports of equivalence/noninferiority trials published in 2003 and 2004.”
From Understanding Equivalence and Noninferiority Testing (2011) · cites this paper as [14]
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- Authors
- Le Henanff, A., Giraudeau, B., Baron, G., & Ravaud, P.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2006-03-08
- Volume
- 295
- Issue
- 10
- Pages
- 1147
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2164963279
- Cited by
- 263
- References
- 1
- Citations by year
- 2026: 1 · 2025: 9 · 2024: 9 · 2023: 6 · 2022: 5 · 2021: 13 · 2020: 2 · 2019: 10 · 2018: 11 · 2017: 19 · 2016: 10 · 2015: 7 · 2014: 18 · 2013: 16 · 2012: 22
- FWCI
- 19.15
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- JAMA (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
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- equivalence trials, reporting quality, randomized controlled trials, non-inferiority margin, sample size determination, intention-to-treat analysis, per-protocol analysis, confidence intervals
- MeSH terms
- Publishing, Research Design, Therapeutic Equivalency, Reproducibility of Results, Bias, Randomized Controlled Trials as Topic
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