Journal of Biopharmaceutical Statistics, Volume 23, Issue 5 (2013)

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Journal of Biopharmaceutical Statistics, Volume 23, Issue 5 (2013)

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Editorials

Editorial
Research Outcomes and Recommendations for the Assessment of Progression in Cancer Clinical Trials
Will Bushnell & Andrew Stone
Pages: 949-950
Published online: 19 Aug 2013
CitationforResearch Outcomes and Recommendations for the Assessment of Progression in Cancer Clinical Trials | Full Text | References | PDF (51.2 KB)
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Original Articles

Article
Missing Data and Censoring in the Analysis of Progression-Free Survival in Oncology Clinical Trials
J. S. Denne, A. M. Stone, R. Bailey-Iacona & T.-T. Chen
Pages: 951-970
Published online: 19 Aug 2013
AbstractforMissing Data and Censoring in the Analysis of Progression-Free Survival in Oncology Clinical Trials | Full Text | References | PDF (280.1 KB)
  • 1306 Views
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Article
Evaluation of Discordance Measures in Oncology Studies with Blinded Independent Central Review of Progression-Free Survival Using an Observational Error Model
F. V. Mannino, O. Amit & S. Lahiri
Pages: 971-985
Published online: 19 Aug 2013
AbstractforEvaluation of Discordance Measures in Oncology Studies with Blinded Independent Central Review of Progression-Free Survival Using an Observational Error Model | Full Text | References | PDF (433.9 KB)
  • 406 Views
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Article
A Review of Statistical Issues with Progression-Free Survival as an Interval-Censored Time-to-Event Endpoint
Xing Sun, Xiaoyun Li, Cong Chen & Yang Song
Pages: 986-1003
Published online: 19 Aug 2013
AbstractforA Review of Statistical Issues with Progression-Free Survival as an Interval-Censored Time-to-Event Endpoint | Full Text | References | PDF (189 KB)
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Article
Estimating the Effect of Multiple Imputation on Incomplete Longitudinal Data with Application to a Randomized Clinical Study
Daniel Y. T. Fong, Shesh N. Rai & Karen S. L. Lam
Pages: 1004-1022
Published online: 19 Aug 2013
AbstractforEstimating the Effect of Multiple Imputation on Incomplete Longitudinal Data with Application to a Randomized Clinical Study | Full Text | References | PDF (135.1 KB)
  • 204 Views
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Article
Bayesian Inference for Skew-Normal Mixture Models With Left-Censoring
Getachew A. Dagne
Pages: 1023-1041
Published online: 19 Aug 2013
AbstractforBayesian Inference for Skew-Normal Mixture Models With Left-Censoring | Full Text | References | PDF (405.1 KB)
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Article
A Note on Partial Covariate-Adjustment and Design Considerations in Noninferiority Trials When Patient-Level Data are not Available
Lei Nie, Guoxing (Greg) Soon, Karen Qi, Yong Chen & Haitao Chu
Pages: 1042-1053
Published online: 19 Aug 2013
AbstractforA Note on Partial Covariate-Adjustment and Design Considerations in Noninferiority Trials When Patient-Level Data are not Available | Full Text | References | PDF (112.8 KB)
  • 113 Views
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Article
A Consistency Approach for Evaluation of Biosimilar Products
Hsiao-Hui Tsou, Wan-Jung Chang, Wong-Shian Hwang & Yi-Hsuan Lai
Pages: 1054-1066
Published online: 19 Aug 2013
AbstractforA Consistency Approach for Evaluation of Biosimilar Products | Full Text | References | PDF (117 KB)
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Article
Optimal Timing for Interim Analyses in Clinical Trials
Kanae Togo & Manabu Iwasaki
Pages: 1067-1080
Published online: 19 Aug 2013
AbstractforOptimal Timing for Interim Analyses in Clinical Trials | Full Text | References | PDF (485.7 KB)
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Article
Randomized Two-Stage Phase II Clinical Trial Designs Based on Barnard's Exact Test
Guogen Shan, Changxing Ma, Alan D. Hutson & Gregory E. Wilding
Pages: 1081-1090
Published online: 19 Aug 2013
AbstractforRandomized Two-Stage Phase II Clinical Trial Designs Based on Barnard's Exact Test | Full Text | References | PDF (108 KB)
  • 265 Views
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Article
Evaluating and Adjusting for Premature Censoring of Progression-Free Survival
Mark Rothmann, Kallappa Koti, Kyung Yul Lee, Hong Laura Lu, Yuan Li Shen, Jenny J. Zhang, Mei Jin & Haojin Zhou
Pages: 1091-1105
Published online: 19 Aug 2013
AbstractforEvaluating and Adjusting for Premature Censoring of Progression-Free Survival | Full Text | References | PDF (171.1 KB)
  • 264 Views
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Article
An Analytical Approach to Assess the Predictive Value of Biomarkers in Phase II Decision Making
Stavros Nikolakopoulos, Willem M. van der Wal & Kit C. B. Roes
Pages: 1106-1123
Published online: 19 Aug 2013
AbstractforAn Analytical Approach to Assess the Predictive Value of Biomarkers in Phase II Decision Making | Full Text | References | PDF (910 KB)
  • 261 Views
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Article
An Adaptive Two-Stage Dose-Response Design Method for Establishing Proof of Concept
Yoko Franchetti, Stewart J. Anderson & Allan R. Sampson
Pages: 1124-1154
Published online: 19 Aug 2013
AbstractforAn Adaptive Two-Stage Dose-Response Design Method for Establishing Proof of Concept | Full Text | References | PDF (660.5 KB)
  • 308 Views
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Article
Joint Modeling of Clinical Efficacy and Safety with an Application to Diabetes Studies
Yang Zhao, Wei Shen & Haoda Fu
Pages: 1155-1171
Published online: 19 Aug 2013
AbstractforJoint Modeling of Clinical Efficacy and Safety with an Application to Diabetes Studies | Full Text | References | PDF (746.9 KB)
  • 237 Views
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Article
A Comparison of Bias-Corrected Covariance Estimators for Generalized Estimating Equations
Chunpeng Fan, Donghui Zhang & Cun-Hui Zhang
Pages: 1172-1187
Published online: 19 Aug 2013
AbstractforA Comparison of Bias-Corrected Covariance Estimators for Generalized Estimating Equations | Full Text | References | PDF (162.9 KB)
  • 259 Views
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Article
Decision Making from Phase II to Phase III and the Probability of Success: Reassured by “Assurance”?
Kevin J. Carroll
Pages: 1188-1200
Published online: 19 Aug 2013
AbstractforDecision Making from Phase II to Phase III and the Probability of Success: Reassured by “Assurance”? | Full Text | References | PDF (186 KB)
  • 1050 Views
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Book Reviews

Book Review
Book Review
John R. Cook
Pages: 1201-1203
Published online: 19 Aug 2013
First Page PreviewforBook Review | Full Text | PDF (53 KB)
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Article
Book Review
Annpey Pong
Pages: 1204-1206
Published online: 19 Aug 2013
First Page PreviewforBook Review | Full Text | References | PDF (58.4 KB)
  • 66 Views
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