64th ISI World Statistics Congress - Ottawa, Canada

64th ISI World Statistics Congress - Ottawa, Canada

Bayesian Adaptive Design for clinical trials with potential subgroup effects

Author

XZ
Xuekui Zhang

Co-author

  • L
    Li Xing
  • S
    Shuyi Long
  • B
    Belaid Moa
  • C
    Cong Chen, Shentu Yue

Conference

64th ISI World Statistics Congress - Ottawa, Canada

Format: IPS Abstract

Keywords: bayesian, multipletesting

Session: IPS 379 - Innovative Designs and Statistical Inference for Clinical Trials

Thursday 20 July 10 a.m. - noon (Canada/Eastern)

Abstract

Many designs of clinical trials face the challenge of two sources of uncertainty. First, to calculate the statistical power of a clinical trial, traditional design methods require users to provide the value of drug efficacy. However, investigating drug efficacy is the aim of the clinical trial, and hence, its true value is never known. Second, many modern clinical trials have a potential subgroup effect. But, drug developers often are unsure if a predefined subgroup of patients can respond to the drug better than the entire population before the clinical trial is conducted. In this talk, we present a novel Bayesian adaptive design, that correctly handles these two uncertainties to help design a better clinical trial.