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Evidence-based sizing of non-inferiority trials using decision models.

Iris Lansdorp-VogelaarReshma JagsiJinani JayasekeraNatasha K StoutSandra A MitchellEric J Feuer
Published 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.
Keyphrases
  • phase iii
  • study protocol
  • phase ii
  • clinical trial
  • decision making
  • open label
  • double blind