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结合专家先验的延迟治疗效应自适应临床试验设计AI 解读

Clinical trials with time-to-event endpoints, such as overall survival (OS) or progression-free survival (PFS), are fundamental for evaluating new treatments, particularly in immuno-oncology. However, modern therapies, such as immunotherapies and targeted treatments, often exhibit delayed effects that challenge traditional trial designs. These delayed effects violate the proportional hazards assumption, which underpins standard statistical methods like the Cox proportional…

延迟治疗效应下临床试验设计的保证概率方法AI 解读

An assurance calculation is a Bayesian alternative to a power calculation. One may be performed to aid the planning of a clinical trial, specifically setting the sample size or to support decisions about whether or not to perform a study. Immuno-oncology is a rapidly evolving area in the development of anticancer drugs. A common phenomenon that arises in trials of such drugs is one of delayed treatment effects, that is, there is a delay in the separation of the survival…