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## Abstract 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 is the prespecified fraction __f__ of unknown effect size of the reference drug, where the prespecified fraction __f__ is treated as if it were a revised margin. Therefore, these methods cannot be applied to the case where the acceptable non‐inferiority margin must be a prespecified difference between treatments. In this paper, we propose a statistical test procedure for three‐arm non‐inferiority trials with the margin Δ defined as a prespecified difference between treatments under the situation that the primary endpoints are normally distributed with a common, but unknown, variance. In addition, we derive the optimal allocation that minimizes the total sample size. The propose

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Author

Eisuke Hida; Toshiro Tango

Publisher

John Wiley and Sons; Wiley (John Wiley & Sons); John Wiley & Sons Inc.; Wiley (ISSN 0277-6715)

Published

2010

Language

EN

Field

Mathematics (Physical Sciences)