Methodological developments vs. regulatory requirements

被引：0
|
作者：
Bauer, Peter [1 ]
机构：
[1] Med Univ Vienna, Core Unit Med Stat & Informat, Sect Med Stat, A-1090 Vienna, Austria
来源：
BIOMETRICAL JOURNAL | 2006年 / 48卷 / 04期
关键词：
adaptive designs; adaptive information design; adaptive study designs; biostatistics; clinical trial simulation; dropping a treatment arm; drug safety; estimation; experimental design; FDA critical path; guidance development; multiple endpoints; non-inferiority trials; phase III clinical trials; quantitative risk/safety assessment; regulatory biostatistics; regulatory evaluation; sample size reassessment; statistical efficiency; statistical information; superiority;
D O I：
10.1002/bimj.200610244
中图分类号：
Q [生物科学];
学科分类号：
07 ; 0710 ; 09 ;
摘要：
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 I 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.
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页码：609 / 612
页数：4
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