值得 发表于 2025-3-26 23:53:27
https://doi.org/10.1007/978-90-481-9667-8method (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.尾巴 发表于 2025-3-27 03:07:28
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Phase I Designs for Late-Onset Toxicitychapter 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.表状态 发表于 2025-3-27 22:09:14
Optimal Biological Dose and Phase I/II Trials 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.Hallmark 发表于 2025-3-28 05:17:50
Model-Based Designs for Identification of Optimal Biological Dose-toxicity and dose-efficacy model, and continuously update the estimate of the model in a way similar to the continual reassessment method (CRM). The model estimate is then used to guide dose escalation/de-escalation. Herein, the software of these designs is introduced.BACLE 发表于 2025-3-28 09:34:13
https://doi.org/10.1007/978-3-031-05871-4 U-BOIN have the advantages of being simple to implement and meanwhile yielding competitive performances. Conducting the trial does not require complicated model estimation. The decision of dose transition can be easily made by looking up the pre-generated decision table. Examples and software are provided to illustrate BOIN12 and U-BOIN.强所 发表于 2025-3-28 10:35:43
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