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Adaptive designs from the viewpoint of an academic biostatistician.

作者信息

Schäfer Helmut

机构信息

Institute of Medical Biometry and Epidemiology, Philipps-University Marburg, Germany.

出版信息

Biom J. 2006 Aug;48(4):586-90; discussion 613-22. doi: 10.1002/bimj.200610246.

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

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