Abstract
Single-arm phase II trials are common in cancer research and provide a useful approach to screen and identify promising treatments that warrant phase III trials, using small sample sizes. This chapter first presents Simon’s two-stage design; and then introduces several novel Bayesian designs, including posterior probability (PrP) and predictive probability (PreP) approaches, and Bayesian optimal Phase II design (BOP2) and its extensions. Bayesian designs, particularly BOP2, provide a highly flexible and efficient approach to addressing the complexity of immunotherapies and targeted therapies; such as ordinal endpoints, multiple endpoints, co-primary endpoints, and multiple interim analyses.
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Pan, H., Yuan, Y. (2023). Single Arm Phase II Clinical Trial. In: Bayesian Adaptive Design for Immunotherapy and Targeted Therapy. Springer, Singapore. https://doi.org/10.1007/978-981-19-8176-0_6
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DOI: https://doi.org/10.1007/978-981-19-8176-0_6
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