A consultant's perspective on the regulatory hurdles to adaptive trials

被引：2
|
作者：
Mehta, Cyrus R. [1 ]
Jemiai, Yannis [1 ]
机构：
[1] Cytel Inc, Cambridge, MA 02139 USA
来源：
BIOMETRICAL JOURNAL | 2006年 / 48卷 / 04期
关键词：
adaptive designs; adaptive information design; biostatistics; dropping a treatment arm; experimental design; flexible design; non-inferiority; phase III clinical trials; statistical efficiency; regulatory evaluation; statistical information; superiority;
D O I：
10.1002/bimj.200610249
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 two papers appearing in this special issue on adaptive designs: '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.
引用
收藏
页码：604 / 608
页数：5
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