实施适应性设计的挑战：对监管统计学家观点的评论
Challenges in implementing adaptive designs: comments on the viewpoints expressed by regulatory statisticians.
作者信息
Gallo Paul, Maurer Willi
机构信息
Novartis Pharmaceuticals, East Hanover, NJ, USA.
出版信息
Biom J. 2006 Aug;48(4):591-7; discussion 613-22. doi: 10.1002/bimj.200610250.
PMID:16972710
Abstract
This is a discussion of the following three papers appearing in this special issue on adaptive designs: 'FDA's critical path initiative: A perspective on contributions of biostatistics' by Robert T. O'Neill; 'A regulatory view on adaptive/flexible clinical trial design' by H. M. James Hung, Robert T. O'Neill, Sue-Jane Wang and John Lawrence; and 'Confirmatory clinical trials with an adaptive design' by Armin Koch.
摘要
以下是对本期关于适应性设计的特刊中发表的三篇论文的讨论
罗伯特·T·奥尼尔所著的《美国食品药品监督管理局的关键路径计划：生物统计学贡献之展望》；H.M.詹姆斯·洪、罗伯特·T·奥尼尔、苏简·王和约翰·劳伦斯所著的《适应性/灵活临床试验设计的监管视角》；以及阿明·科赫所著的《采用适应性设计的验证性临床试验》。
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1
Challenges in implementing adaptive designs: comments on the viewpoints expressed by regulatory statisticians.实施适应性设计的挑战：对监管统计学家观点的评论
Biom J. 2006 Aug;48(4):591-7; discussion 613-22. doi: 10.1002/bimj.200610250.
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Opening the adaptive toolbox.打开适应性工具箱。
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Adaptive designs from the viewpoint of an academic biostatistician.
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Methodological developments vs. regulatory requirements.
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FDA's critical path initiative: a perspective on contributions of biostatistics.美国食品药品监督管理局的关键路径计划：生物统计学贡献之展望
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