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Volume 24, Issue 1

Journal of Biopharmaceutical Statistics

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Journal of Biopharmaceutical Statistics, Volume 24, Issue 1 (2014)

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Journal of Biopharmaceutical Statistics, Volume 24, Issue 1 (2014)

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Subgroup Analysis in Clinical Trials

Editorial

Guest Editors’ Note: Special Issue on Subgroup Analysis in Clinical Trials

Sue-Jane Wang & Alex Dmitrienko

Pages: 1-3

Published online: 06 Jan 2014

First Page PreviewforGuest Editors’ Note: Special Issue on Subgroup Analysis in Clinical Trials | Full Text | References | PDF (52 KB)

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Original Articles

Article

An Overview of Statistical and Regulatory Issues in the Planning, Analysis, and Interpretation of Subgroup Analyses in Confirmatory Clinical Trials

Robert Hemmings

Pages: 4-18

Published online: 06 Jan 2014

AbstractforAn Overview of Statistical and Regulatory Issues in the Planning, Analysis, and Interpretation of Subgroup Analyses in Confirmatory Clinical Trials | Full Text | References | PDF (374 KB)

975 Views
18 CrossRef citations
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Article

A Regulatory Perspective on Essential Considerations in Design and Analysis of Subgroups When Correctly Classified

Sue-Jane Wang & H. M. James Hung

Pages: 19-41

Published online: 06 Jan 2014

AbstractforA Regulatory Perspective on Essential Considerations in Design and Analysis of Subgroups When Correctly Classified | Full Text | References | PDF (437.3 KB)

845 Views
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Article

Reliably Basing Conclusions on Subgroups of Randomized Clinical Trials

Armin Koch & Theodor Framke

Pages: 42-57

Published online: 06 Jan 2014

AbstractforReliably Basing Conclusions on Subgroups of Randomized Clinical Trials | Full Text | References | PDF (115.2 KB)

516 Views
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Article

Subgroups: Time to Go Back to Basic Statistical Principles?

Oliver N. Keene & Andrew D. Garrett

Pages: 58-71

Published online: 06 Jan 2014

AbstractforSubgroups: Time to Go Back to Basic Statistical Principles? | Full Text | References | PDF (172.6 KB)

741 Views
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Article

An Overview of Statistical Planning to Address Subgroups in Confirmatory Clinical Trials

Gary G. Koch & Todd A. Schwartz

Pages: 72-93

Published online: 06 Jan 2014

AbstractforAn Overview of Statistical Planning to Address Subgroups in Confirmatory Clinical Trials | Full Text | References | PDF (162.5 KB)

717 Views
24 CrossRef citations
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Article

Bayesian Assessment of the Influence and Interaction Conditions in Multipopulation Tailoring Clinical Trials

Brian A. Millen, Alex Dmitrienko & Guochen Song

Pages: 94-109

Published online: 06 Jan 2014

AbstractforBayesian Assessment of the Influence and Interaction Conditions in Multipopulation Tailoring Clinical Trials | Full Text | References | PDF (220.5 KB)

463 Views
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Article

A Bayesian Approach to Subgroup Identification

James O. Berger, Xiaojing Wang & Lei Shen

Pages: 110-129

Published online: 06 Jan 2014

AbstractforA Bayesian Approach to Subgroup Identification | Full Text | References | PDF (150.6 KB)

1967 Views
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Article

Strategies for Identifying Predictive Biomarkers and Subgroups with Enhanced Treatment Effect in Clinical Trials Using SIDES

Ilya Lipkovich & Alex Dmitrienko

Pages: 130-153

Published online: 06 Jan 2014

AbstractforStrategies for Identifying Predictive Biomarkers and Subgroups with Enhanced Treatment Effect in Clinical Trials Using SIDES | Full Text | References | PDF (187.6 KB)

1178 Views
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Article

Standardization for Subgroup Analysis in Randomized Controlled Trials

Ravi Varadhan & Sue-Jane Wang

Pages: 154-167

Published online: 06 Jan 2014

AbstractforStandardization for Subgroup Analysis in Randomized Controlled Trials | Full Text | References | PDF (119.1 KB)

865 Views
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Article

Adaptive Designs for Confirmatory Clinical Trials with Subgroup Selection

Nigel Stallard, Thomas Hamborg, Nicholas Parsons & Tim Friede

Pages: 168-187

Published online: 06 Jan 2014

AbstractforAdaptive Designs for Confirmatory Clinical Trials with Subgroup Selection | Full Text | References | PDF (1.4 MB)

1031 Views
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Article

Decision Rules for Subgroup Selection Based on a Predictive Biomarker

Johannes Krisam & Meinhard Kieser

Pages: 188-202

Published online: 06 Jan 2014

AbstractforDecision Rules for Subgroup Selection Based on a Predictive Biomarker | Full Text | References | PDF (391.1 KB)

607 Views
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Book Reviews

Book Review

Book Review: Joint Models for Longitudinal and Time-to-Event Data: With Applications in R, by Dimitris Rizopoulos

Boca Raton, FL: Chapman & Hall/CRC Biostatistics Series, 2012, ISBN 978-1439872864, 275 pp., $79.95

Lang Wu

Pages: 203-205

Published online: 06 Jan 2014

First Page PreviewforBook Review: Joint Models for Longitudinal and Time-to-Event Data: With Applications in R, by Dimitris Rizopoulos | Full Text | PDF (52.1 KB)

196 Views
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Book Review

Book Review: Design and Analysis of Bridging Studies, edited by J. P. Liu, S. C. Chow, and C. F. Hsiao

Boca Raton, FL: Chapman & Hall/CRC, 2012, ISBN 978-2-4398-4634-6, xviii + 269 pp., $99.95.

William W. B. Wang

Pages: 206-207

Published online: 06 Jan 2014

CitationforBook Review: Design and Analysis of Bridging Studies, edited by J. P. Liu, S. C. Chow, and C. F. Hsiao | Full Text | PDF (50.4 KB)

123 Views
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Book Review

Book Review: Randomized Phase II Cancer Clinical Trials, by Sin-Ho Jung

Boca Raton, FL: Chapman & Hall/CRC Biostatistics Series, 2013, ISBN 978-1-4398-7185-0 (hardcover, 289 pp., $89.95

Steven Sun

Pages: 208-210

Published online: 06 Jan 2014

First Page PreviewforBook Review: Randomized Phase II Cancer Clinical Trials, by Sin-Ho Jung | Full Text | References | PDF (52.7 KB)

97 Views
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Journal of Biopharmaceutical Statistics (Vol.24, Iss.1, 2014)

Subgroup Analysis in Clinical Trials

Subgroup Analysis in Clinical Trials

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