Journal of Biopharmaceutical Statistics, Volume 20, Issue 6 (2010)

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Journal of Biopharmaceutical Statistics, Volume 20, Issue 6 (2010)

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Special Theme for Adaptive Clinical Trial Designs

Original Articles

Article
Editorial: Adaptive Designs: Appealing in Development of Therapeutics, and Where do Controversies Lie?
Sue-Jane Wang
Pages: 1083-1087
Published online: 05 Nov 2010
First Page PreviewforEditorial: Adaptive Designs: Appealing in Development of Therapeutics, and Where do Controversies Lie? | Full Text | References | PDF (63.4 KB)
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Article
A Note on Special Articles on Adaptive Clinical Trial Designs
Shein-Chung Chow
Pages: 1088-1089
Published online: 05 Nov 2010
CitationforA Note on Special Articles on Adaptive Clinical Trial Designs | Full Text | PDF (47.6 KB)
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Article
Perspectives on the Use of Adaptive Designs in Clinical Trials. Part I. Statistical Considerations and Issues
Sue-Jane Wang
Pages: 1090-1097
Published online: 05 Nov 2010
AbstractforPerspectives on the Use of Adaptive Designs in Clinical Trials. Part I. Statistical Considerations and Issues | Full Text | References | PDF (79 KB)
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Article
Perspectives on the Use of Adaptive Designs in Clinical Trials. Part II. Panel Discussion
Norbert Benda, Werner Brannath, Frank Bretz, Hans-Ulrich Burger, Tim Friede, Willi Maurer & Sue-Jane Wang
Pages: 1098-1112
Published online: 05 Nov 2010
AbstractforPerspectives on the Use of Adaptive Designs in Clinical Trials. Part II. Panel Discussion | Full Text | References | PDF (106.2 KB)
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Article
Introduction to Discussion Papers on Draft FDA Guidance on Adaptive Designs
Mark Chang
Pages: 1113-1114
Published online: 05 Nov 2010
CitationforIntroduction to Discussion Papers on Draft FDA Guidance on Adaptive Designs | Full Text | PDF (46.7 KB)
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Article
Viewpoints on the FDA Draft Adaptive Designs Guidance from the PhRMA Working Group
Paul Gallo, Keaven Anderson, Christy Chuang-Stein, Vladimir Dragalin, Brenda Gaydos, Michael Krams & José Pinheiro
Pages: 1115-1124
Published online: 05 Nov 2010
AbstractforViewpoints on the FDA Draft Adaptive Designs Guidance from the PhRMA Working Group | Full Text | References | PDF (86.7 KB)
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Article
Comments on the Draft Guidance on “Adaptive Design Clinical Trials for Drugs and Biologics” of the U.S. Food and Drug Administration
Werner Brannath, Hans Ulrich Burger, Ekkehard Glimm, Nigel Stallard, Marc Vandemeulebroecke & Gernot Wassmer
Pages: 1125-1131
Published online: 05 Nov 2010
AbstractforComments on the Draft Guidance on “Adaptive Design Clinical Trials for Drugs and Biologics” of the U.S. Food and Drug Administration | Full Text | References | PDF (79.2 KB)
  • 305 Views
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Article
Review of Draft FDA Adaptive Design Guidance
Thomas Cook & David L. DeMets
Pages: 1132-1142
Published online: 05 Nov 2010
AbstractforReview of Draft FDA Adaptive Design Guidance | Full Text | References | PDF (96.3 KB)
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Article
FDA Draft Guidance on Adaptive Design Clinical Trials: Pfizer's Perspective
Christy Chuang-Stein & Mohan Beltangady
Pages: 1143-1149
Published online: 05 Nov 2010
AbstractforFDA Draft Guidance on Adaptive Design Clinical Trials: Pfizer's Perspective | Full Text | References | PDF (76.3 KB)
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Article
Adaptive Methods: Telling “The Rest of the Story”
Scott S. Emerson & Thomas R. Fleming
Pages: 1150-1165
Published online: 05 Nov 2010
AbstractforAdaptive Methods: Telling “The Rest of the Story” | Full Text | References | PDF (260.5 KB)
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Article
Comments on the FDA Draft Guidance on Adaptive Designs
Janet Wittes
Pages: 1166-1170
Published online: 05 Nov 2010
First Page PreviewforComments on the FDA Draft Guidance on Adaptive Designs | Full Text | References | PDF (173.7 KB)
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Article
On Flexibility of Adaptive Designs and Criteria for Choosing A Good One—A Discussion of FDA Draft Guidance
Bin Cheng & Shein-Chung Chow
Pages: 1171-1177
Published online: 05 Nov 2010
AbstractforOn Flexibility of Adaptive Designs and Criteria for Choosing A Good One—A Discussion of FDA Draft Guidance | Full Text | References | PDF (78.8 KB)
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Article
Understanding the FDA Guidance on Adaptive Designs: Historical, Legal, and Statistical Perspectives
Qing Liu & George Y. H. Chi
Pages: 1178-1219
Published online: 05 Nov 2010
AbstractforUnderstanding the FDA Guidance on Adaptive Designs: Historical, Legal, and Statistical Perspectives | Full Text | References | PDF (320.8 KB)
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Book Reviews

Book Review
A Review of: “Multiple Testing Problems in Pharmaceutical Statistics, by A. Dmitrienko, A. C. Tamhane, and F. Bretz (Eds.)”
Boca Raton, FL: Chapman & Hall/CRC, 2010, ISBN 978-1-58488-984-7, xvi + 304 pp., $89.95.
Vera Lisovskaja & Carl-Fredrik Burman
Pages: 1220-1222
Published online: 05 Nov 2010
First Page PreviewforA Review of: “Multiple Testing Problems in Pharmaceutical Statistics, by A. Dmitrienko, A. C. Tamhane, and F. Bretz (Eds.)” | Full Text | PDF (53.8 KB)
  • 72 Views
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Book Review
A Review of: “Medical Statistics at a Glance, Third Edition, by A. Petrie and C. Sabin”
Chichester, UK: Wiley-Blackwell, 2009, ISBN 978-1-4051-8051-1, 180 pp., $38.95.
Sunil K. Dhar
Pages: 1223-1224
Published online: 05 Nov 2010
CitationforA Review of: “Medical Statistics at a Glance, Third Edition, by A. Petrie and C. Sabin” | Full Text | PDF (52.5 KB)
  • 175 Views
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Book Review
A Review of: “Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, by G. A. Walker and J. Shostak”
Cary, NC: SAS Institute, Inc., 2010, ISBN 978-1-60764-228-2, xiv + 536 pp., $79.95.
Neepa Ray
Pages: 1225-1226
Published online: 05 Nov 2010
CitationforA Review of: “Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, by G. A. Walker and J. Shostak” | Full Text | PDF (49.8 KB)
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