BioPharmNet forum
This page is maintained by the PhRMA adaptive design working group (Alex Dmitrienko).
White papers
White papers released by the Working Group.
Paul Gallo, Michael Krams. PhRMA Working Group on Adaptive Designs: Introduction to the Full White Paper. Drug Information Journal. 2006; 40: 421-423.
Vladimir Dragalin. Adaptive Designs: Terminology and Classification. Drug Information Journal. 2006; 40: 425-435 [Download paper].
Judith Quinlan, Michael Krams. Implementing adaptive designs: logistical and operational considerations. Drug Information Journal 2006; 40: 437-444 [Download paper].
Paul Gallo. Confidentiality and Trial Integrity Issues for Adaptive Designs. Drug Information Journal. 2006; 40: 445-450.
Brenda Gaydos, Michael Krams, Inna Perevozskaya, Frank Bretz, Qing Liu, Paul Gallo, Don Berry, Christy Chuang-Stein, Jose Pinheiro, Alun Bedding. Adaptive Dose-Response Studies. Drug Information Journal. 2006; 40: 451-461 [Download paper].
Jeff Maca, Suman Bhattacharya, Vladimir Dragalin, Paul Gallo, Michael Krams. Adaptive Seamless Phase II/II Designs-Background, Operational Aspects, and Examples. Drug Information Journal. 2006; 40: 463-473 [Download paper].
Christy Chuang-Stein, Keaven Anderson, Paul Gallo, Sylva Collins. Sample Size Reestimation: A Review and Recommendations. Drug Information Journal. 2006; 40: 475-484 [Download paper].
Paul Gallo, Christy Chuang-Stein, Vladimir Dragalin, Brenda Gaydos, Michael Krams, Josť Pinheiro. Executive Summary of the PhRMA Working Group on Adaptive Designs in Clinical Drug Development. Journal of Biopharmaceutical Statistics. 2006; 16: 275-283.
PhRMA Adaptive Design Working Group, Adaptive designs software requirements subgroup. Adaptive Trials - User Requirements for Statistical Simulation and Analysis Software [Download paper].
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