A consultant's perspective on the regulatory hurdles to adaptive trials.
作者信息
Mehta Cyrus R, Jemiai Yannis
机构信息
Cytel Inc., 675 Massachusetts Ave., Cambridge, MA 02139-3309, USA.
出版信息
Biom J. 2006 Aug;48(4):604-8; discussion 613-22. doi: 10.1002/bimj.200610249.
PMID:16972712
Abstract
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.
摘要
Zotero 插件