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

页码：604 / 608

页数：5

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