This page is maintained by the PhRMA
adaptive design working group (
Alex
Dmitrienko).
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, José Pinheiro. Executive
Summary of the PhRMA Working Group on Adaptive Designs in Clinical
Drug Development. Journal of Biopharmaceutical Statistics. 2006; 16: 275-283.
