Phase I Designs for Late-Onset Toxicity

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 2 in Bayesian Adaptive Design for Immunotherapy and Targeted Therapy, 2023, pp 15-43 from Springer

Abstract: 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.

Date: 2023
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DOI: 10.1007/978-981-19-8176-0_2

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