• J Biopharm Stat · Jan 2007

    Adaptive designs in clinical drug development: opportunities, challenges, and scope reflections following PhRMA's November 2006 workshop.

    • Michael Krams, Carl-Fredrik Burman, Vladimir Dragalin, Brenda Gaydos, Andrew P Grieve, Jose Pinheiro, Willi Maurer, and Paul Gallo.
    • Wyeth Research, Collegeville, Pennsylvania 19426, USA. kramsm@wyeth.com
    • J Biopharm Stat. 2007 Jan 1; 17 (6): 957-64.

    AbstractThis paper provides reflections on the opportunities, scope and challenges of adaptive design as discussed at PhRMA's workshop held in November 2006. We also provide a status report of workstreams within PhRMA's working group on adaptive designs, which were triggered by the November workshop. Rather than providing a comprehensive review of the presentations given, we limit ourselves to a selection of key statements. The authors reflect the position of PhRMA's working group on adaptive designs.

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