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.
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Pan, H., Yuan, Y. (2023). Optimal Biological Dose and Phase I/II Trials. In: Bayesian Adaptive Design for Immunotherapy and Targeted Therapy. Springer, Singapore. https://doi.org/10.1007/978-981-19-8176-0_3
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DOI: https://doi.org/10.1007/978-981-19-8176-0_3
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