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Group sequential multi-arm multi-stage trial design with treatment selection.
Wu, Jianrong; Li, Yimei; Zhu, Liang.
Afiliación
  • Wu J; Division of Epidemiology, Biostatistics, and Preventive Medicine University of New Mexico, Albuquerque, New Mexico, USA.
  • Li Y; Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
  • Zhu L; Internal Medicine, University of Texas Health Science Center, Houston, Texas, USA.
Stat Med ; 42(10): 1480-1491, 2023 05 10.
Article en En | MEDLINE | ID: mdl-36808736
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.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Proyectos de Investigación Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Humans Idioma: En Revista: Stat Med Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Proyectos de Investigación Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Humans Idioma: En Revista: Stat Med Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos