Bayesian Phase 1–2 Designs with Adaptive Rules for Staggering Patient Entry
具有自适应患者错峰入组规则的贝叶斯Ⅰ—Ⅱ期试验设计
For first-in-human dose-finding trials, to protect patient safety, regulatory agencies may enforce strict within-cohort staggering rules that require delaying treatment of each patient in the first cohort at an untried dose until dose-limiting toxicities (DLTs) of all previously treated patients have been evaluated. Consequently, many new patients may face therapy delays, which reduces their probability of achieving a response due to disease progression, or be treated…