Designs of superiority and noninferiority trials for binary responses are noninterchangeable

DOI10.1002/BIMJ.200510288MaRDI QIDQ5122887zbMATH OpenOpenAlexWikidataFDO

Authors Joan F. Hilton

Publication date 24 September 2020

Published in Biometrical Journal (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1002/bimj.200510288

zbMATH Keywords

variancenuisance parameterrandomized controlled trialallocation ratio

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10)

Recommendations

• Design and analysis of non-inferiority trials
• Statistical methods for the analysis of two-arm non-inferiority trials with binary outcomes
• A group sequential type design for three-arm non-inferiority trials with binary endpoints
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• Re-formulating non-inferiority trials as superiority trials: the case of binary outcomes

Cited in

(7)

• Non-inferiority testing for risk ratio, odds ratio and number needed to treat in three-arm trial
• Design and analysis of non-inferiority trials
• Sequential parallel comparison design for ``gold standard noninferiority trials with a prespecified margin
• A mixed approach for proving non-inferiority in clinical trials with binary endpoints
• Re-formulating non-inferiority trials as superiority trials: the case of binary outcomes
• A group sequential type design for three-arm non-inferiority trials with binary endpoints
• Two-stage winner designs for non-inferiority trials with pre-specified non-inferiority margin

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