STUDY DURATION FOR CLINICAL-TRIALS WITH SURVIVAL RESPONSE AND EARLY STOPPING RULE
STUDY DURATION FOR CLINICAL-TRIALS WITH SURVIVAL RESPONSE AND EARLY STOPPING RULE
复制标题
DOI：
10.2307/2531632
复制
发表时间：
1990-03-01
期刊：
影响因子：
1.9
通讯作者：
TSIATIS, AA
中科院分区：
文献类型：
--
作者：
KIM, K;TSIATIS, AA
一项具有内置顺序停药规则的比较性临床试验允许早于计划停药，如果有明显的治疗复发指征。在一项主要结局是对某一事件（如失败）的时间（生存时间或反应）的临床试验中，研究设计应确定需要多长时间招募患者并进行随访，直到在整个研究期间观察到足够数量的事件。本文提出了一种具有生存效应的成组序贯临床试验的统一设计方法。假设事件发生时间呈指数分布，但在时间尺度上进行适当变换后，参数自然扩展到比例风险模型。从东部肿瘤协作组（ECOG）的一个例子来说明这个过程可以实现。同一个例子是用来探索的整体操作特性和稳健性的建议组序贯设计。
A comparative clinical trial with built-in sequential stopping rules allows earlier-than-scheduled stopping, should there be a significant indication of treatment differecne. In a clinical trial where the major outcome is time (survival time or response) to a certain event such as failure, the design of the study should determine how long one needs to accrue patients and follow through until there is a sufficient number of events observed during the entire study duration. This paper proposes a unified design procedure for group sequential clinical trials with survival response. The time to event is assumed to be exponentially distributed, but the arguments extend naturally to the proportional hazards model after suitable transformation on the time scale. An example from the Eastern cooperative Oncology Group (ECOG) is given to illustrate how this procedure can be implemented. The same example is used to explore the overall operating characteristics and the robustness of the proposed group sequential design.