A group sequential clinical trial design can be an attractive option when planning a pivotal trial as this approach has the ability to stop the trial early for success, whilst also being well accepted from a regulatory review perspective. Compared to a single stage design there are more moving parts to consider and optimise when planning a group sequential trial. This tutorial briefly outlines the group sequential methodology before detailing some of the key operating characteristics and how these can be estimated, optimised and ultimately presented to decision makers when aligning on a final study design.

翻译：组序贯临床试验设计在规划关键性试验时是一种具有吸引力的选择，因为该方法能够提前终止试验以宣告成功，同时从监管审评角度看也易于被接受。与单阶段设计相比，组序贯试验在规划时需要考虑和优化的动态要素更多。本教程在简要概述组序贯方法论后，详细阐述若干关键操作特征，以及如何对这些特征进行评估、优化，并最终在确定最终研究设计时向决策者呈现。