Multi-arm multi-stage survival trial design with arm-specific stopping rule.

Jianrong Wu, Yimei Li, Liang Zhu, Tushar Patni
Author Information
  1. Jianrong Wu: Biostatistics Shared Resource Facility, University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA.
  2. Yimei Li: Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.
  3. Liang Zhu: Department of Internal Medicine, University of Texas Health Science Center, Houston, TX, USA.
  4. Tushar Patni: Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.

Abstract

Traditional two-arm randomized trial designs have played a pivotal role in establishing the efficacy of medical interventions. However, their efficiency is often compromised when confronted with multiple experimental treatments or limited resources. In response to these challenges, the multi-arm multi-stage designs have emerged, enabling the simultaneous evaluation of multiple treatments within a single trial. In such an approach, if an arm meets efficacy success criteria at an interim stage, the whole trial stops and the arm is selected for further study. However when multiple treatment arms are active, stopping the trial at the moment one arm achieves success diminishes the probability of selecting the best arm. To address this issue, we have developed a group sequential multi-arm multi-stage survival trial design with an arm-specific stopping rule. The proposed method controls the familywise type I error in a strong sense and selects the best promising treatment arm with a high probability.

Keywords

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Grants

  1. P30 CA118100/NCI NIH HHS

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