FDA Draft Guidance on Adaptive Design Clinical Trials: Pfizer's Perspective
FDA Draft Guidance on Adaptive Design Clinical Trials: Pfizer's Perspective
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DOI：
10.1080/10543406.2010.514456
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发表时间：
2010-01-01
影响因子：
1.1
通讯作者：
Beltangady, Mohan
中科院分区：
文献类型：
--
作者：
Chuang-Stein, Christy;Beltangady, Mohan
2010年2月，美国食品和药物管理局发布了适应性设计临床试验指南草案。由于近年来制药行业对适应性试验的兴趣日益浓厚，本指南草案引起了广泛关注。在本文中，我们报告了辉瑞公司对该指南草案收集的意见的重点。此外，我们还分享了辉瑞自2005年以来促进高效试验设计的内部历程。适应性设计是这一过程的一部分。
The Food and Drug Administration of the United States issued a draft guidance on adaptive design clinical trials in February 2010. This draft guidance has attracted a lot of attention because of the increasing interest in adaptive trials by the pharmaceutical industry in recent years. In this paper, we report on highlights of comments collected within Pfizer on this draft guidance. In addition, we share Pfizer's internal journey to promote efficient trial designs since 2005. Adaptive designs have been part of that journey.