Group-Sequential Methods for Adaptive Seamless Phase II/III Clinical Trials
Group-Sequential Methods for Adaptive Seamless Phase II/III Clinical Trials
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DOI：
10.1080/10543406.2011.551335
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发表时间：
2011-01-01
影响因子：
1.1
通讯作者：
Stallard, Nigel
中科院分区：
文献类型：
--
作者：
Stallard, Nigel
在过去的10年里，人们对允许在一项临床试验中无缝结合II期和III期的临床试验设计产生了相当大的兴趣。这种设计将选择最有希望的治疗方法（通常在II期临床试验中进行）与III期临床试验所需的I型错误率的严格分析和控制结合在一起。从统计学上讲，挑战在于允许对累积数据进行重复分析和根据最终分析中将包括的数据选择治疗方法进行多重比较。这一挑战可以通过若干不同的方式来应对。本文综述了基于成组序贯方法的序贯临床试验监测方法。该文件的主要重点将是对方法的描述，包括在早期中期分析中使用短期数据进行决策的设置。
The last 10 years have seen considerable interest in clinical trial designs that allow the seamless combination of Phases II and III in a single clinical trial. Such designs bring together the selection of the most promising of a number of treatments, as usually performed in a Phase II clinical trial, with the rigorous analysis and control of type I error rates required for a Phase III clinical trial. Statistically, the challenge is that of allowing for multiple comparisons arising both from repeated analyses of the accumulating data and from selection of a treatment on the basis of data that will be included in the final analysis. This challenge can be met in a number of different ways. This paper reviews methods based on the group-sequential methodology for monitoring of sequential clinical trials. The main focus of the paper will be a description of the methodology, including the setting in which short-term data are used for decision making at an early interim analysis.