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具有自适应患者错峰入组规则的贝叶斯Ⅰ—Ⅱ期试验设计AI 解读

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…

免疫治疗的贝叶斯 I/II 期临床试验设计AI 解读

Immunotherapy is an innovative treatment approach that stimulates a patient's immune system to fight cancer. It demonstrates characteristics distinct from conventional chemotherapy and stands to revolutionize cancer treatment. We propose a Bayesian phase I/II dosefinding design that incorporates the unique features of immunotherapy by simultaneously considering three outcomes: immune response, toxicity and efficacy. The objective is to identify the biologically optimal dose,…

用数据增广支持结局延迟的一至二期临床试验AI 解读

A practical impediment in adaptive clinical trials is that outcomes must be observed soon enough to apply decision rules to choose treatments for new patients. For example, if outcomes take up to six weeks to evaluate and the accrual rate is one patient per week, on average three new patients will be accrued while waiting to evaluate the outcomes of the previous three patients. The question is how to treat the new patients. This logistical problem persists throughout the…