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Bayesian Phase II Single-Arm Designs

In: Frontiers of Biostatistical Methods and Applications in Clinical Oncology

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  • Satoshi Teramukai

    (Kyoto Prefectural University of Medicine, Department of Biostatistics, Graduate School of Medical Science)

Abstract

Phase II exploratory clinical trials in oncology are often designed as single-arm trialsSingle-arm trial using a binary efficacyEfficacy outcome with or without interim monitoring. This chapter focused on the BayesianBayes/Bayesian designs which considered both efficacy and safety outcomes associated with early stopping. In particular, we introduce a Bayesian adaptive design denoted as predictive sample size selection designPredictive sample size selection design (PSSD). The design allows for sample size selection following any planned interim analyses for early stopping of a trial, together with sample size determination. An extension of the PSSD to add continuous monitoring of safety is also described. We investigate the operating characteristics of the design through simulation studies.

Suggested Citation

  • Satoshi Teramukai, 2017. "Bayesian Phase II Single-Arm Designs," Springer Books, in: Shigeyuki Matsui & John Crowley (ed.), Frontiers of Biostatistical Methods and Applications in Clinical Oncology, pages 65-84, Springer.
    • Handle: RePEc:spr:sprchp:978-981-10-0126-0_6
    DOI: 10.1007/978-981-10-0126-0_6
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