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PubMed · 16972713

Methodological developments vs. regulatory requirements.

Peter Bauer
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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.

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BiometryClinical Trials as TopicData Interpretation, StatisticalResearch DesignSample SizeCommentJournal Article

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Peter Bauer. 2006. Methodological developments vs. regulatory requirements.. https://doi.org/10.1002/bimj.200610244

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