Statistics in Biopharmaceutical Research, Volume 8, Issue 3 (2016)

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Statistics in Biopharmaceutical Research, Volume 8, Issue 3 (2016)

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Papers from the 2015 ASA Biopharmaceutical Section Statistics Workshop

Editorials

Editorial
Guest Editors’ Note
Richard C. Zink & Wei Zhang
Page: 229
Published online: 16 Sep 2016
CitationforGuest Editors’ Note | Full Text | PDF (167.6 KB)
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Original Articles

Article
Incorporating Patient Preferences into Medical Device Benefit-Risk Assessments
Telba Irony, Martin Ho, Stephanie Christopher & Bennett Levitan
Pages: 230-236
Published online: 16 Sep 2016
AbstractforIncorporating Patient Preferences into Medical Device Benefit-Risk Assessments | Full Text | References | PDF (709.9 KB)
  • 360 Views
  • 11 CrossRef citations
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Article
Adaptive Informational Design of Confirmatory Phase III Trials With an Uncertain Biomarker Effect to Improve the Probability of Success
Cong Chen, Nicole Li, Yue Shentu, Lei Pang & Robert A. Beckman
Pages: 237-247
Published online: 16 Sep 2016
AbstractforAdaptive Informational Design of Confirmatory Phase III Trials With an Uncertain Biomarker Effect to Improve the Probability of Success | Full Text | References | PDF (683.3 KB) | Supplemental
  • 355 Views
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Article
Statistical Design and Considerations of a Phase 3 Basket Trial for Simultaneous Investigation of Multiple Tumor Types in One Study
Cong Chen, Xiaoyun (Nicole) Li, Shuai Yuan, Zoran Antonijevic, Rasika Kalamegham & Robert A. Beckman
Pages: 248-257
Published online: 16 Sep 2016
AbstractforStatistical Design and Considerations of a Phase 3 Basket Trial for Simultaneous Investigation of Multiple Tumor Types in One Study | Full Text | References | PDF (783.9 KB) | Supplemental
  • 988 Views
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Article
Location Bias in ROC Studies
Lucy D'Agostino McGowan, Jennifer A. Bullen & Nancy A. Obuchowski
Pages: 258-267
Published online: 16 Sep 2016
AbstractforLocation Bias in ROC Studies | Full Text | References | PDF (925.7 KB)
  • 148 Views
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Article
Sample Size and Power of Survival Trials in Group Sequential Design With Delayed Treatment Effect
Jianliang Zhang & Erik Pulkstenis
Pages: 268-275
Published online: 25 Jul 2016
AbstractforSample Size and Power of Survival Trials in Group Sequential Design With Delayed Treatment Effect | Full Text | References | PDF (570.8 KB)
  • 252 Views
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Article
Interim Futility Analysis for Longitudinal Data With Adaptive Timing and Error Rate Preservation
GengQian Cai, Jacquie A. Christie, Graeme E. Archer & Tianhui Zhou
Pages: 276-281
Published online: 16 Sep 2016
AbstractforInterim Futility Analysis for Longitudinal Data With Adaptive Timing and Error Rate Preservation | Full Text | References | PDF (383.8 KB) | Supplemental
  • 220 Views
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Article
A Note on Good Practice of Objective Propensity Score Design for Premarket Nonrandomized Medical Device Studies with an Example
Heng Li, Vandana Mukhi, Nelson Lu, Yun-Ling Xu & Lilly Q. Yue
Pages: 282-286
Published online: 16 Sep 2016
AbstractforA Note on Good Practice of Objective Propensity Score Design for Premarket Nonrandomized Medical Device Studies with an Example | Full Text | References | PDF (481.2 KB)
  • 514 Views
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Article
Concepts, Methods, and Practical Considerations of Meta-Analysis in Drug Development
Zhenming Shun, Gao Lei, Qianying Liu, Wei Zheng, Hui Quan & Simon Hitier
Pages: 287-292
Published online: 16 Sep 2016
AbstractforConcepts, Methods, and Practical Considerations of Meta-Analysis in Drug Development | Full Text | References | PDF (345.3 KB)
  • 217 Views
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Article
On Group Sequential Enrichment Design for Basket Trial
Shuai S. Yuan, Aiying Chen, Li He, Cong Chen, Christine K. Gause & Robert A. Beckman
Pages: 293-306
Published online: 16 Sep 2016
AbstractforOn Group Sequential Enrichment Design for Basket Trial | Full Text | References | PDF (944.5 KB)
  • 380 Views
  • 6 CrossRef citations
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Article
Equivalence Test for Two Emax Response Curves
Bo Jin & Kerry B. Barker
Pages: 307-315
Published online: 16 Sep 2016
AbstractforEquivalence Test for Two Emax Response Curves | Full Text | References | PDF (610.6 KB)
  • 159 Views
  • 5 CrossRef citations
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Article
Bayesian Approach to Personalized Benefit-Risk Assessment
Shiqi Cui, Yueqin Zhao & Ram C. Tiwari
Pages: 316-324
Published online: 16 Sep 2016
AbstractforBayesian Approach to Personalized Benefit-Risk Assessment | Full Text | References | PDF (703.6 KB)
  • 275 Views
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Article
Thresholding of a Continuous Companion Diagnostic Test Confident of Efficacy in Targeted Population
Yi Liu, Szu-Yu Tang, Michael Man, Ying Grace Li, Stephen J. Ruberg, Eloise Kaizar & Jason C. Hsu
Pages: 325-333
Published online: 01 Jul 2016
AbstractforThresholding of a Continuous Companion Diagnostic Test Confident of Efficacy in Targeted Population | Full Text | References | PDF (521.5 KB)
  • 191 Views
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Article
A Meta-Analysis of Missing Data and Non-Compliance Data in Clinical Endpoint Bioequivalence Studies
Wanjie Sun, Lingjie Zhou, Stella Grosser & Carol Kim
Pages: 334-344
Published online: 16 Sep 2016
AbstractforA Meta-Analysis of Missing Data and Non-Compliance Data in Clinical Endpoint Bioequivalence Studies | Full Text | References | PDF (934.6 KB)
  • 230 Views
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Article
On the Use of Co-Data in Clinical Trials
Beat Neuenschwander, Satrajit Roychoudhury & Heinz Schmidli
Pages: 345-354
Published online: 16 Sep 2016
AbstractforOn the Use of Co-Data in Clinical Trials | Full Text | References | PDF (584.3 KB)
  • 1876 Views
  • 39 CrossRef citations
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Article
Statistical Methods for Clinical Validation of Follow-On Companion Diagnostic Devices via an External Concordance Study
Meijuan Li
Pages: 355-363
Published online: 16 Sep 2016
AbstractforStatistical Methods for Clinical Validation of Follow-On Companion Diagnostic Devices via an External Concordance Study | Full Text | References | PDF (378.5 KB)
  • 1169 Views
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Indices

Index
Editorial Board
Page: ebi
Published online: 16 Sep 2016
CitationforEditorial Board | Full Text | PDF (19.8 KB)
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