Journal of Biopharmaceutical Statistics, Volume 32, Issue 3 (2022)

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Journal of Biopharmaceutical Statistics, Volume 32, Issue 3 (2022)

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Special issue on Emerging Clinical Initiatives in Pharmaceutical Development: Methodology and Regulatory Perspectives

Comment

Emerging clinical initiatives in pharmaceutical development: methodology and regulatory perspectives
Nelson Lu & Herbert Pang
Pages: 357-358
Published online: 10 Jun 2022
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Research Article

Article
A Bayesian group sequential design for randomized biosimilar clinical trials with adaptive information borrowing from historical data
Wen Zhang, Zhiying Pan & Ying Yuan
Pages: 359-372
Published online: 09 Jun 2022
AbstractforA Bayesian group sequential design for randomized biosimilar clinical trials with adaptive information borrowing from historical data | Full Text | References | PDF (624.7 KB) | EPUB
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Article
Utilizing stratified generalized propensity score matching to approximate blocked randomized designs with multiple treatment levels
Nathan Corder & Shu Yang
Pages: 373-399
Published online: 19 Jun 2022
AbstractforUtilizing stratified generalized propensity score matching to approximate blocked randomized designs with multiple treatment levels | Full Text | References | PDF (3 MB) | EPUB
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Article
Propensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies
Wei-Chen Chen, Nelson Lu, Chenguang Wang, Heng Li, Changhong Song, Ram Tiwari, Yunling Xu & Lilly Q. Yue
Pages: 400-413
Published online: 08 Jun 2022
AbstractforPropensity score-integrated approach to survival analysis: leveraging external evidence in single-arm studies | Full Text | References | PDF (1.2 MB) | EPUB | Supplemental
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Article
What is the expected benefit of patient-centric clinical development in oncology?
Alessandra Serra, Pavel Mozgunov, Thomas Jaki & Fabio Rigat
Pages: 414-426
Published online: 18 Jul 2022
AbstractforWhat is the expected benefit of patient-centric clinical development in oncology? | Full Text | References | PDF (1.1 MB) | EPUB | Supplemental
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Open Access
Article
Conditional power in vaccine trials with seasonal variations
Xinyu Tang, Lihan K. Yan & John A. Scott
Pages: 427-440
Published online: 29 Jun 2022
AbstractforConditional power in vaccine trials with seasonal variations | Full Text | References | PDF (1.8 MB) | EPUB
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Article
Randomization tests in clinical trials with multiple imputation for handling missing data
Anastasia Ivanova, Seth Lederman, Philip B. Stark, Gregory Sullivan & Ben Vaughn
Pages: 441-449
Published online: 06 Jun 2022
AbstractforRandomization tests in clinical trials with multiple imputation for handling missing data | Full Text | References | PDF (869.4 KB) | EPUB
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Article
Statistical learning in preclinical drug proarrhythmic assessment
Nan Miles Xi, Yu-Yi Hsu, Qianyu Dang & Dalong Patrick Huang
Pages: 450-473
Published online: 30 Jun 2022
AbstractforStatistical learning in preclinical drug proarrhythmic assessment | Full Text | References | PDF (4.4 MB) | EPUB | Supplemental
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Article
A structured framework for adaptively incorporating external evidence in sequentially monitored clinical trials
Evan Kwiatkowski, Eugenio Andraca-Carrera, Mat Soukup & Matthew A. Psioda
Pages: 474-495
Published online: 07 Jul 2022
AbstractforA structured framework for adaptively incorporating external evidence in sequentially monitored clinical trials | Full Text | References | PDF (2.1 MB) | EPUB
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Article
Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials
Ariadna Garcia, Vidhya Balasubramanian, Justin Lee, Rebecca Gardner, Santosh Gummidipundi, Grace Hung, Todd Ferris, Lauren Cheung, Christopher Granger, Peter Kowey, John Rumsfeld, Andrea Russo, Mellianie Ture Hills, Nisha Talati, Divya Nag, Jeffrey Stein, David Tsay, Sumbul Desai, Kenneth Mahaffey, Mintu Turakhia, Marco Perez, Haley Hedlin & Manisha Desai
Pages: 496-510
Published online: 12 Jun 2022
AbstractforLessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials | Full Text | References | PDF (2.2 MB) | EPUB
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Open Access
Article
Consideration of the adaptive randomization allocation ratio in the presence of treatment group heteroscedasticity in clinical trials
Jiashen Lu & Yeh-Fong Chen
Pages: 511-526
Published online: 13 Jun 2022
AbstractforConsideration of the adaptive randomization allocation ratio in the presence of treatment group heteroscedasticity in clinical trials | Full Text | References | PDF (834.6 KB) | EPUB
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