Optimal Biological Dose and Phase I/II 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 3 in Bayesian Adaptive Design for Immunotherapy and Targeted Therapy, 2023, pp 47-52 from Springer

Abstract: Abstract The conventional phase I trial design paradigm is based on the more-is-better assumption, which may not be true for immunotherapies and targeted therapies. For these novel therapies, efficacy may plateau or even decrease at high doses, and dose limiting toxicity may be rare. In this case, it is more appropriate to identify the optimal biological dose (OBD) that optimizes the risk-benefit tradeoff of the treatment, rather than the maximum tolerated dose (MTD). This chapter reviews basic concepts of the OBD and the phase I/II design paradigm to find the OBD.

Date: 2023
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-981-19-8176-0_3

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DOI: 10.1007/978-981-19-8176-0_3

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