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Introduction to Phase I Dose-Finding Clinical Trials

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

The primary objective of phase I oncology trials is to identify the maximum tolerated dose (MTD) of an investigational drug to inform the dose to be investigated in subsequent phases of development. This chapter review several novel phase I designs for oncology, including the continual reassessment method (CRM), modified toxicity probability interval design (mTPI), Keyboard design, and Bayesian optimal interval design (BOIN). Characteristics of these designs are explained and contrasted. Unique challenges of using phase I trials for immunotherapies and targeted therapies are described.

Suggested Citation

  • Haitao Pan & Ying Yuan, 2023. "Introduction to Phase I Dose-Finding Clinical Trials," Springer Books, in: Bayesian Adaptive Design for Immunotherapy and Targeted Therapy, chapter 0, pages 3-14, Springer.
    • Handle: RePEc:spr:sprchp:978-981-19-8176-0_1
    DOI: 10.1007/978-981-19-8176-0_1
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