Design and Interpretation of Noninferiority Trials
- PMID: 29948802
- PMCID: PMC6082220
- DOI: 10.1007/s11606-018-4504-9
Design and Interpretation of Noninferiority Trials
Keywords: clinical trials; comparative effectiveness; research design.
Conflict of interest statement
The authors declare that they do not have a conflict of interest.
None.
Comment in
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Design and Interpretation of Noninferiority Trials.J Gen Intern Med. 2018 Aug;33(8):1217. doi: 10.1007/s11606-018-4505-8. J Gen Intern Med. 2018. PMID: 29845472 Free PMC article. No abstract available.
Comment on
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Empirical Consequences of Current Recommendations for the Design and Interpretation of Noninferiority Trials.J Gen Intern Med. 2018 Jan;33(1):88-96. doi: 10.1007/s11606-017-4161-4. Epub 2017 Sep 5. J Gen Intern Med. 2018. PMID: 28875400 Free PMC article. Review.
References
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- Guidance for industry non-inferiority clinical trials: draft guidance [Internet]. Silver Spring (MD): U.S. Department of Health and Human Services, Food and Drug Administration. c2010. F. Potential biases in an NI study. p. 33. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati... (Accessed 2015 Aug 7).
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