INTERIM ANALYSES IN RANDOMIZED CLINICAL-TRIALS - RAMIFICATIONS AND GUIDELINES FOR PRACTITIONERS
INTERIM ANALYSES IN RANDOMIZED CLINICAL-TRIALS - RAMIFICATIONS AND GUIDELINES FOR PRACTITIONERS
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DOI：
10.2307/2531962
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发表时间：
1987-03-01
期刊：
影响因子：
1.9
通讯作者：
POCOCK, SJ
中科院分区：
文献类型：
--
作者：
GELLER, NL;POCOCK, SJ
近年来，成组序贯方法的发展对随机临床试验的设计和分析产生了巨大的影响。使用几个真实的试验作为例证，讨论了计划和非计划中期分析的后果。进行中期分析的指导方针，包括表的名义显着性水平和所需的样本量为几个组序贯计划。需要进一步理论进步的领域包括多个终点、治疗差异的估计、分层和多组试验的设计。
Recent developments in group sequential methods have had a great impact on the design and analysis of randomized clinical trials. The consequences for both planned and unplanned interim analyses are discussed using several real trials as illustrations. Guidelines for the conduct of interim analysis are given, including tables of nominal significance levels and required sample sizes for several group sequential plans. Areas in need of further theoretical advance include multiple endpoints, estimation of treatment differences, stratification, and design of multiple-armed trials.