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Biom J. 2006 Aug;48(4):609-12; discussion 613-22.

Methodological developments vs. regulatory requirements.

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


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.

[Indexed for MEDLINE]

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