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This page is maintained by the PhRMA adaptive
design working group ( Alex
Dmitrienko). White papers
White papers released by the Working Group.
References
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, José 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]. |
