Introduction to Phase I Dose-Finding Clinical Trials

Haitao Pan () and Ying Yuan ()
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Haitao Pan: St. Jude Children’s Research Hospital, Department of Biostatistics
Ying Yuan: The University of Texas MD Anderson Cancer Center, Department of Biostatistics

Chapter Chapter 1 in Bayesian Adaptive Design for Immunotherapy and Targeted Therapy, 2023, pp 3-14 from Springer

Abstract: 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.

Date: 2023
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DOI: 10.1007/978-981-19-8176-0_1

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