Group-Sequential Three-Arm Non-inferiority Clinical Trials

  • Toshimitsu Hamasaki
  • Koko Asakura
  • Scott R. Evans
  • Toshimitsu Ochiai
Chapter
Part of the SpringerBriefs in Statistics book series (BRIEFSSTATIST)

Abstract

We discuss group-sequential three-arm non-inferiority (NI) clinical trials, i.e., trials that include a test intervention as well as active and placebo controls for evaluating both assay sensitivity and NI. We extend two existing approaches, the fixed margin and fraction approaches, to a group-sequential setting with two decision-making frameworks. We provide an example to illustrate the methods.

Keywords

Assay sensitivity Average sample number Constancy Fixed margin approach Fraction approach Maximum sample size Non-inferiority Type I error 

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Copyright information

© The Author(s) 2016

Authors and Affiliations

  • Toshimitsu Hamasaki
    • 1
  • Koko Asakura
    • 2
  • Scott R. Evans
    • 3
  • Toshimitsu Ochiai
    • 4
  1. 1.Department of Data ScienceNational Cerebral and Cardiovascular CenterSuitaJapan
  2. 2.Department of Data ScienceNational Cerebral and Cardiovascular CenterSuitaJapan
  3. 3.Department of Biostatistics and the Center for Biostatistics in AIDS ResearchHarvard T.H. Chan School of Public HealthBostonUSA
  4. 4.Biostatistics DepartmentShionogi & Co., Ltd.OsakaJapan

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