Adaptive designs for pivotal trials: discussion points from the PSI Adaptive Design Expert Group
Adaptive designs for pivotal trials: discussion points from the PSI Adaptive Design Expert Group
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关键试验的自适应设计：PSI 自适应设计专家组的讨论要点
作者：
A. Phillips;O. Keene
人用药品委员会（CHMP）目前正在准备一份关于“具有灵活设计和分析计划的验证性临床试验中的方法学问题”的指南。PSI（制药行业统计学家）主办了一次对该领域感兴趣的制药统计学家会议，以分享经验并确定后期临床药物开发中适应性设计的潜在机会。本文概述了提出的问题、讨论结果和达成的一致意见。
The Committee for Medicinal Products for Human Use (CHMP) is currently preparing a guideline on ‘methodological issues in confirmatory clinical trials with flexible design and analysis plan’. PSI (Statisticians in the Pharmaceutical Industry) sponsored a meeting of pharmaceutical statisticians with an interest in the area to share experiences and identify potential opportunities for adaptive designs in late‐phase clinical drug development. This article outlines the issues raised, resulting discussions and consensus views reached.