A Consultant's Perspective on the Regulatory Hurdles to Adaptive Trials

This is a discussion of the following two papers appearing in this special issue on adaptive designs: ‘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. (© 2006 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)

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