On the three-arm non-inferiority trial including a placebo with a prespecified margin.

@article{Hida2011OnTT,
  title={On the three-arm non-inferiority trial including a placebo with a prespecified margin.},
  author={Eisuke Hida and Toshiro Tango},
  journal={Statistics in medicine},
  year={2011},
  volume={30 3},
  pages={224-31}
}
Three-arm trials including the experimental treatment, an active reference treatment and a placebo are recommended in the guidelines of the ICH and EMEA/CPMP as a useful approach to the assessment of assay sensitivity. Generally, the acceptable non-inferiority margin Δ has been defined as the maximum clinically irrelevant difference between treatments in many two-arm non-inferiority trials. However, many recent articles discussing three-arm trials have considered a design with unknown Δ which… CONTINUE READING
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