Journal of Biopharmaceutical Statistics, Volume 29, Issue 4 (2019)

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Journal of Biopharmaceutical Statistics, Volume 29, Issue 4 (2019)

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Special Issue: Real Word Experience and Randomized Clinical Trials

Guest Editor’s note

Editorial
Guest editors’ note on special issue on real-world experience and randomized clinical trials
Jean Pan & D. Y. Lin
Page: 579
Published online: 30 Jul 2019
CitationforGuest editors’ note on special issue on real-world experience and randomized clinical trials | Full Text | PDF (118.3 KB) | EPUB
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Free Access

Articles

Article
Good statistical practice in utilizing real-world data in a comparative study for premarket evaluation of medical devices
Nelson Lu, Yunling Xu & Lilly Q. Yue
Pages: 580-591
Published online: 29 Jun 2019
AbstractforGood statistical practice in utilizing real-world data in a comparative study for premarket evaluation of medical devices | Full Text | References | PDF (855.9 KB) | EPUB
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Article
Bias-adjusted Kaplan–Meier survival curves for marginal treatment effect in observational studies
Xiaofei Wang, Fangfang Bai, Herbert Pang & Stephen L George
Pages: 592-605
Published online: 09 Jul 2019
AbstractforBias-adjusted Kaplan–Meier survival curves for marginal treatment effect in observational studies | Full Text | References | PDF (1.1 MB) | EPUB | Supplemental
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Article
Robust outcome weighted learning for optimal individualized treatment rules
Sheng Fu, Qinying He, Sanguo Zhang & Yufeng Liu
Pages: 606-624
Published online: 16 Jul 2019
AbstractforRobust outcome weighted learning for optimal individualized treatment rules | Full Text | References | PDF (1.5 MB) | EPUB | Supplemental
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Article
Rapid enrollment design for finding the optimal dose in immunotherapy trials with ordered groups
Xiaoqiang Xue, Matthew C Foster & Anastasia Ivanova
Pages: 625-634
Published online: 28 Jun 2019
AbstractforRapid enrollment design for finding the optimal dose in immunotherapy trials with ordered groups | Full Text | References | PDF (746.8 KB) | EPUB
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Article
Generalization of the time-to-event continual reassessment method to bivariate outcomes
Donglin Yan, Christopher Tait, Nolan A. Wages, Tamila Kindwall-Keller & Emily V. Dressler
Pages: 635-647
Published online: 02 Jul 2019
AbstractforGeneralization of the time-to-event continual reassessment method to bivariate outcomes | Full Text | References | PDF (1.3 MB) | EPUB | Supplemental
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Article
On the relative efficiency of model-assisted designs: a conditional approach
Ruitao Lin & Ying Yuan
Pages: 648-662
Published online: 29 Jun 2019
AbstractforOn the relative efficiency of model-assisted designs: a conditional approach | Full Text | References | PDF (1.3 MB) | EPUB
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Article
Power calculation in stepped-wedge cluster randomized trial with reduced intervention sustainability effect
Jing Li, Ying Zhang, Laura J. Myers & Dawn M. Bravata
Pages: 663-674
Published online: 18 Jul 2019
AbstractforPower calculation in stepped-wedge cluster randomized trial with reduced intervention sustainability effect | Full Text | References | PDF (1.2 MB) | EPUB
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Article
Finding the intended use population for a new treatment
Richard Simon & Noah Simon
Pages: 675-684
Published online: 15 Jul 2019
AbstractforFinding the intended use population for a new treatment | Full Text | References | PDF (727.1 KB) | EPUB
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Article
Estimating the subgroup and testing for treatment effect in a post-hoc analysis of a clinical trial with a biomarker
Neha Joshi, Jason Fine, Rong Chu & Anastasia Ivanova
Pages: 685-695
Published online: 04 Jul 2019
AbstractforEstimating the subgroup and testing for treatment effect in a post-hoc analysis of a clinical trial with a biomarker | Full Text | References | PDF (813.1 KB) | EPUB
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Article
Randomization-based analysis of covariance for inference in the sequential parallel comparison design
Laura E. Wiener, Anastasia Ivanova, Siying Li, Rachel K. Silverman & Gary G. Koch
Pages: 696-713
Published online: 15 Jul 2019
AbstractforRandomization-based analysis of covariance for inference in the sequential parallel comparison design | Full Text | References | PDF (1.2 MB) | EPUB
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Article
Applying CHW method to 2-in-1 design: gain or lose?
Xiaofei Bai & Qiqi Deng
Pages: 714-721
Published online: 25 Jun 2019
AbstractforApplying CHW method to 2-in-1 design: gain or lose? | Full Text | References | PDF (1.1 MB) | EPUB
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Article
Commentary on “Applying CHW method to 2-in-1 design: gain or lose”
Lu Cui, H.M. James Hung & Sue Jane Wang
Pages: 722-727
Published online: 29 Jun 2019
AbstractforCommentary on “Applying CHW method to 2-in-1 design: gain or lose” | Full Text | References | PDF (497.2 KB) | EPUB
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Book Review

Book Review
Bioequivalence and Statistics in Clinical Pharmacology
by S. Patterson and B. Jones, 2017, Chapman and Hall/CRC: Boca Raton, FL 33487-2742. 434 pp., + xxv, £76.99, Hardback, ISBN 9781584885306
Julie Bertrand PhD
Pages: 728-729
Published online: 03 Oct 2017
CitationforBioequivalence and Statistics in Clinical Pharmacology | Full Text | References | PDF (207.5 KB) | EPUB
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