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Phase I Designs for Late-Onset Toxicity

In: Bayesian Adaptive Design for Immunotherapy and Targeted Therapy

Author

Listed:
  • Haitao Pan

    (St. Jude Children’s Research Hospital, Department of Biostatistics)

  • Ying Yuan

    (The University of Texas MD Anderson Cancer Center, Department of Biostatistics)

Abstract

Late-onset toxicity is common for immunotherapies and targeted therapies. It causes major logistic difficulty in conducting phase I trials using most existing phase I designs, which require that toxicity can be observed quickly to inform the dose assignment for the next new cohort of patients. This chapter introduces three model-based designs, including the time-to-event CRM (TITE-CRM), fractional CRM (fCRM), data augmentation CRM (DA-CRM), and a model-assisted design, i.e., time-to-event BOIN (TITE-BOIN), to deal with late-onset toxicity. Trial examples and software are provided to demonstrate the implementation of designs.

Suggested Citation

  • Haitao Pan & Ying Yuan, 2023. "Phase I Designs for Late-Onset Toxicity," Springer Books, in: Bayesian Adaptive Design for Immunotherapy and Targeted Therapy, chapter 0, pages 15-43, Springer.
    • Handle: RePEc:spr:sprchp:978-981-19-8176-0_2
    DOI: 10.1007/978-981-19-8176-0_2
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