Group sequential multi-arm multi-stage trial design with treatment selection.

Jianrong Wu, Yimei Li, Liang Zhu
Author Information
  1. Jianrong Wu: Division of Epidemiology, Biostatistics, and Preventive Medicine University of New Mexico, Albuquerque, New Mexico, USA. ORCID
  2. Yimei Li: Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
  3. Liang Zhu: Internal Medicine, University of Texas Health Science Center, Houston, Texas, USA.

Abstract

A multi-arm trial allows simultaneous comparison of multiple experimental treatments with a common control and provides a substantial efficiency advantage compared to the traditional randomized controlled trial. Many novel multi-arm multi-stage (MAMS) clinical trial designs have been proposed. However, a major hurdle to adopting the group sequential MAMS routinely is the computational effort of obtaining total sample size and sequential stopping boundaries. In this paper, we develop a group sequential MAMS trial design based on the sequential conditional probability ratio test. The proposed method provides analytical solutions for futility and efficacy boundaries to an arbitrary number of stages and arms. Thus, it avoids complicated computational effort for the methods proposed by Magirr et al. Simulation results showed that the proposed method has several advantages compared to the methods implemented in R package MAMS by Magirr et al.

Keywords

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Grants

  1. P30 CA118100/NCI NIH HHS

MeSH Term

Humans
Research Design
Patient Selection
Sample Size
Computer Simulation

Word Cloud

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