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Challenges in implementing adaptive designs: comments on the viewpoints expressed by regulatory statisticians.

Paul Gallo·Willi Maurer
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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, Phase III as TopicResearch DesignUnited StatesUnited States Food and Drug AdministrationCommentJournal Article

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Paul Gallo, Willi Maurer. 2006. Challenges in implementing adaptive designs: comments on the viewpoints expressed by regulatory statisticians.. https://doi.org/10.1002/bimj.200610250

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