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A framework for considering the risk-benefit trade-off in designing noninferiority trials using composite outcome approaches

When a new treatment regimen is expected to have comparable or slightly worse efficacy to that of the control regimen but has benefits in other domains such as safety and tolerability, a non-inferiority (NI) trial may be appropriate but is fraught with difficulty in justifying an acceptable NI margi...

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Bibliografiske detaljer
Udgivet i:Stat Med
Main Authors: Montepiedra, Grace, Ramchandani, Ritesh, Miyahara, Sachiko, Kim, Soyeon
Format: Artigo
Sprog:Inglês
Udgivet: 2020
Fag:
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC7770022/
https://ncbi.nlm.nih.gov/pubmed/33105524
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/sim.8777
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