Lessons From and Cautions About Noninferiority and Equivalence Randomized Trials
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An important cause of the confusion is the lack of uniformity and transparency in terminology.
“An important cause of the confusion is the lack of uniformity and transparency in terminology 15 .”
From Understanding Equivalence and Noninferiority Testing (2011) · cites this paper as [15]
Cites
Chan, A.-W., Hróbjartsson, A., Haahr, M. T., Gøtzsche, P. C., & Altman, D. G. (2004) · JAMA · doi:10.1001/jama.291.20.2457 · Cited by 1,845 · see citing works
Self-citationAls-Nielsen, B., Chen, W., Gluud, C., & Kjaergard, L. L. (2003) · JAMA · doi:10.1001/jama.290.7.921 · Cited by 746 · see citing works
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Understanding Equivalence and Noninferiority Testing
Walker, E., & Nowacki, A. S. (2011) · Journal of General Internal Medicine · doi:10.1007/s11606-010-1513-8 · Cited by 751 · see citing works
Loeb, M., Dafoe, N., Mahony, J., John, M., Sarabia, A., Glavin, V., Webby, R., Smieja, M., Earn, D. J. D., Chong, S., et al. (2009) · JAMA · doi:10.1001/jama.2009.1466 · Cited by 465 · see citing works
Bone morphogenetic protein (BMP) for fracture healing in adults
Garrison, K. R., Shemilt, I., Donell, S., Ryder, J. J., Mugford, M., Harvey, I., Song, F., & Alt, V. (2010) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd006950.pub2 · Cited by 278 · see citing works
Eliakim-Raz, N., Yahav, D., Paul, M., & Leibovici, L. (2013) · Journal of Antimicrobial Chemotherapy · doi:10.1093/jac/dkt177 · Cited by 153 · see citing works
Maintenance of weight loss in overweight middle-aged women through the Internet
Cussler, E. C., Teixeira, P. J., Going, S. B., Houtkooper, L. B., Metcalfe, L. L., Blew, R. M., Ricketts, J. R., Lohman, J., Stanford, V. A., & Lohman, T. G. (2008) · Obesity · doi:10.1038/oby.2008.19 · Cited by 115 · see citing works
Randomized controlled trials: what are they and who needs them?
Pihlstrom, B. L., Curran, A. E., Voelker, H. T., & Kingman, A. (2012) · Periodontology 2000 · doi:10.1111/j.1600-0757.2011.00439.x · Cited by 42 · see citing works
Hernandez, A. V., Pasupuleti, V., Deshpande, A., Thota, P., Collins, J. A., & Vidal, J. E. (2013) · PLoS ONE · doi:10.1371/journal.pone.0063272 · Cited by 29 · see citing works
- Authors
- Gøtzsche, P. C.
- Corresponding author
- Gøtzsche, Peter C.
- ORCID
- Gøtzsche, Peter C.
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2006-03-08
- Volume
- 295
- Issue
- 10
- Pages
- 1172
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2060584773
- Cited by
- 106
- References
- 2
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 1 · 2023: 6 · 2022: 2 · 2021: 3 · 2020: 2 · 2019: 4 · 2018: 6 · 2017: 5 · 2016: 2 · 2015: 2 · 2014: 5 · 2013: 11 · 2012: 8
- 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
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- equivalence trials, randomized controlled trials, trial design, statistical inference, clinical trial interpretation
- MeSH terms
- Publishing, Research Design, Therapeutic Equivalency, Randomized Controlled Trials as Topic
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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