Methodological developments vs. regulatory requirements.

作者信息

Bauer Peter

机构信息

Core Unit for Medical Statistics and Informatics, Section of Medical Statistics, Medical University of Vienna, Spitalgasse 23, 1090 Vienna, Austria.

出版信息

Biom J. 2006 Aug;48(4):609-12; discussion 613-22. doi: 10.1002/bimj.200610244.

DOI:10.1002/bimj.200610244

PMID:16972713

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