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A Novel Bayesian Seamless Phase I/II Design

Author

Listed:
  • Haitao Pan
  • Ping Huang
  • Zuoren Wang
  • Ling Wang
  • Chanjuan Li
  • Jielai Xia

Abstract

This paper proposes a novel bayesian phase I/II design featuring using a hybrid mTPI method in phase I for targeting the MTD level and a randomization allocation schema for adaptively assigning patients to desirable doses in phase II. The mechanism of simultaneously escalating dose in phase I and expanding promising doses to phase II is inherited from a design proposed in literature. Extensive simulation studies indicate that our proposed design can vastly save sample size and efficiently assign more patients to optimal dose when compared to two competing designs.

Suggested Citation

  • Haitao Pan & Ping Huang & Zuoren Wang & Ling Wang & Chanjuan Li & Jielai Xia, 2013. "A Novel Bayesian Seamless Phase I/II Design," PLOS ONE, Public Library of Science, vol. 8(9), pages 1-6, September.
    • Handle: RePEc:plo:pone00:0073060
    DOI: 10.1371/journal.pone.0073060
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    References listed on IDEAS

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    1. B. Nebiyou Bekele & Yu Shen, 2005. "A Bayesian Approach to Jointly Modeling Toxicity and Biomarker Expression in a Phase I/II Dose-Finding Trial," Biometrics, The International Biometric Society, vol. 61(2), pages 343-354, June.
    2. Guosheng Yin & Yisheng Li & Yuan Ji, 2006. "Bayesian Dose-Finding in Phase I/II Clinical Trials Using Toxicity and Efficacy Odds Ratios," Biometrics, The International Biometric Society, vol. 62(3), pages 777-787, September.
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