Evidence-based sizing of non-inferiority trials using decision models.
Iris Lansdorp-VogelaarReshma JagsiJinani JayasekeraNatasha K StoutSandra A MitchellEric J FeuerPublished in: BMC medical research methodology (2019)
The example demonstrates that applying our proposed method appears feasible in real-world settings and offers the benefits of more explicit and rigorous quantification of the various considerations relevant for determining a non-inferiority margin and associated trial sample size.