美国食品药品监督管理局关于适应性设计临床试验的草案指南：辉瑞公司的观点。

FDA draft guidance on adaptive design clinical trials: Pfizer's perspective.

作者信息

Chuang-Stein Christy, Beltangady Mohan

机构信息

Statistics, Pfizer, Inc., Kalamazoo, Michigan, USA.

出版信息

J Biopharm Stat. 2010 Nov;20(6):1143-9. doi: 10.1080/10543406.2010.514456.

DOI:10.1080/10543406.2010.514456

PMID:21058110

Abstract

The Food and Drug Administration of the United States issued a draft guidance on adaptive design clinical trials in February 2010. This draft guidance has attracted a lot of attention because of the increasing interest in adaptive trials by the pharmaceutical industry in recent years. In this paper, we report on highlights of comments collected within Pfizer on this draft guidance.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.

摘要

2010年2月，美国食品药品监督管理局发布了一份关于适应性设计临床试验的指南草案。由于近年来制药行业对适应性试验的兴趣日益浓厚，这份指南草案备受关注。在本文中，我们报告了辉瑞公司内部就该指南草案收集到的意见要点。此外，我们还分享了辉瑞公司自2005年以来推动高效试验设计的内部历程。适应性设计一直是这一历程的一部分。