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Optimal Adaptive Phase III Design with Interim Sample Size and Dose Determination

  • Lanju ZhangEmail author
  • Lu Cui
  • Yaoyao Xu
Chapter
Part of the ICSA Book Series in Statistics book series (ICSABSS)

Abstract

Adaptive designs have been proposed to improve clinical trial efficiency. Examples include selecting a treatment arm OR determining a final sample size based on interim data. On the other hand, optimal designs have been proposed to provide robust power against the uncertainty of a planned effect size. In this paper, we propose an optimized 2-stage phase III clinical trial design that combines all these techniques to offer the opportunity of dose selection and sample size determination based on the first stage data with strict type I error rate control and robust power across an effect size interval.

Keywords

Adaptive design Dose selection Robust power Seamless design 

Notes

Disclosure

The support of this publication was provided by AbbVie. AbbVie participated in the review and approval of the content. Lanju Zhang and Lu Cui are employees of AbbVie, Inc. Yaoyao Xu is a former employee of AbbVie and is now employed by PAREXEL International.

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Data and Statistical Sciences, AbbVie Inc.North ChicagoUSA
  2. 2.PAREXEL InternationalDurhamUSA

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