Statistics in Biopharmaceutical Research, Volume 14, Issue 4 (2022)

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Statistics in Biopharmaceutical Research, Volume 14, Issue 4 (2022)

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Special Section: Selected Articles from the ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop 2020 - Lead and Impact: Turning Innovation into Practice

Introduction
Lead and Impact: Turning Innovation into Practice: Selected Articles from RISW2020
Thomas Birkner & Yabing Mai
Page: 397
Published online: 08 Nov 2022
CitationforLead and Impact: Turning Innovation into Practice: Selected Articles from RISW2020 | Full Text | PDF (222.1 KB) | EPUB
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Free Access
Article
Our Most Important Discovery: The Question
Scott R. Evans
Pages: 398-407
Published online: 11 Oct 2021
AbstractforOur Most Important Discovery: The Question | Full Text | References | PDF (6.1 MB) | EPUB
  • 341 Views
  • 1 CrossRef citations
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Article
A Composite Endpoint for Treatment Benefit According to Patient Preference
Ying Lu, Qian Zhao, Jiying Zou, Shiyan Yan, John S. Tamaresis, Lorene Nelson, Xin M. Tu, Jie Chen & Lu Tian
Pages: 408-422
Published online: 19 Jul 2022
AbstractforA Composite Endpoint for Treatment Benefit According to Patient Preference | Full Text | References | PDF (1.5 MB) | EPUB | Supplemental
  • 309 Views
  • 1 CrossRef citations
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Article
Bayesian Optimal Phase II Design for Randomized Clinical Trials
Yujie Zhao, Bo Yang, J. Jack Lee, Li Wang & Ying Yuan
Pages: 423-432
Published online: 21 Apr 2022
AbstractforBayesian Optimal Phase II Design for Randomized Clinical Trials | Full Text | References | PDF (2 MB) | EPUB | Supplemental
  • 788 Views
  • 3 CrossRef citations
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Article
Bayesian Design of Superiority Trials: Methods and Applications
Wenlin Yuan, Ming-Hui Chen & John Zhong
Pages: 433-443
Published online: 18 Jul 2022
AbstractforBayesian Design of Superiority Trials: Methods and Applications | Full Text | References | PDF (1.9 MB) | EPUB | Supplemental
  • 326 Views
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Article
Handling Intercurrent Events Through Hypothetical Strategy in Delayed-Start Designs
Yue Wei, Wen Li, Fang Liu, G. Frank Liu & Richard Entsuah
Pages: 444-455
Published online: 21 Dec 2021
AbstractforHandling Intercurrent Events Through Hypothetical Strategy in Delayed-Start Designs | Full Text | References | PDF (1.3 MB) | EPUB | Supplemental
  • 160 Views
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Article
Strategy for Combining Information from Real World Data Sources When Individual Patient Data Are Not Simultaneously Accessible
Xiwu Lin, Gang Li & Hui Quan
Pages: 456-462
Published online: 13 May 2022
AbstractforStrategy for Combining Information from Real World Data Sources When Individual Patient Data Are Not Simultaneously Accessible | Full Text | References | PDF (739.4 KB) | EPUB
  • 149 Views
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Article
Historical Control Data Borrowing for Noninferiority Assessment
Hui Quan, Zhixing Xu, Meehyung Cho, Yingwen Dong & Nan Jia
Pages: 463-472
Published online: 01 Dec 2021
AbstractforHistorical Control Data Borrowing for Noninferiority Assessment | Full Text | References | PDF (1,005.6 KB) | EPUB
  • 208 Views
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Article
A Quantitative Bias Analysis to Assess Constancy Assumption in Noninferiority Trials Using Bayesian Hierarchical Models
Ying Wu, Yanpeng Wu, Jie Chen & Pingyan Chen
Pages: 473-479
Published online: 30 Jun 2022
AbstractforA Quantitative Bias Analysis to Assess Constancy Assumption in Noninferiority Trials Using Bayesian Hierarchical Models | Full Text | References | PDF (924.6 KB) | EPUB
  • 140 Views
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Article
An Optimal Hybrid Approach to Calculate Conditional Power
Jian Zhu, Xin Li & Yi Liu
Pages: 480-492
Published online: 13 May 2022
AbstractforAn Optimal Hybrid Approach to Calculate Conditional Power | Full Text | References | PDF (1.5 MB) | EPUB | Supplemental
  • 290 Views
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Article
Incorporating Surrogate Information for Adaptive Subgroup Enrichment Design with Sample Size Re-Estimation
Liwen Wu, Qing Li, Mengya Liu & Jianchang Lin
Pages: 493-504
Published online: 01 Apr 2022
AbstractforIncorporating Surrogate Information for Adaptive Subgroup Enrichment Design with Sample Size Re-Estimation | Full Text | References | PDF (2.4 MB) | EPUB
  • 384 Views
  • 4 CrossRef citations
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Article
Backward Sequential Significance Testing in Survival Trials
Michael Gaffney
Pages: 505-510
Published online: 03 Oct 2022
AbstractforBackward Sequential Significance Testing in Survival Trials | Full Text | References | PDF (1.1 MB) | EPUB
  • 56 Views
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Article
Similarity-Principle-Based Machine Learning Method for Clinical Trials and Beyond
Susan Hwang & Mark Chang
Pages: 511-522
Published online: 18 Jul 2022
AbstractforSimilarity-Principle-Based Machine Learning Method for Clinical Trials and Beyond | Full Text | References | PDF (2.8 MB) | EPUB | Supplemental
  • 130 Views
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Article
Value Function Guided Subgroup Identification via Gradient Tree Boosting: A Framework to Handle Multiple Outcomes for Optimal Treatment Recommendation
Pingye Zhang, Peng Liu, Junshui Ma & Yue Shentu
Pages: 523-531
Published online: 04 Oct 2021
AbstractforValue Function Guided Subgroup Identification via Gradient Tree Boosting: A Framework to Handle Multiple Outcomes for Optimal Treatment Recommendation | Full Text | References | PDF (2 MB) | EPUB | Supplemental
  • 135 Views
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Article
Three-Way Mixed Effect ANOVA to Estimate MRMC Limits of Agreement
Si Wen & Brandon D. Gallas
Pages: 532-541
Published online: 11 May 2022
AbstractforThree-Way Mixed Effect ANOVA to Estimate MRMC Limits of Agreement | Full Text | References | PDF (1.6 MB) | EPUB | Supplemental
  • 270 Views
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Research Articles

Article
A Comparative Study on the SWOG Two-Stage Design Extension to Stop Early for Efficacy in Single Arm Phase II Trials
Monica Chaudhari, John Crowley & Antje Hoering
Pages: 542-551
Published online: 01 Feb 2021
AbstractforA Comparative Study on the SWOG Two-Stage Design Extension to Stop Early for Efficacy in Single Arm Phase II Trials | Full Text | References | PDF (2.2 MB) | EPUB
  • 1390 Views
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Open Access
Article
Post-Test Diagnostic Accuracy Measures of a Continuous Test With a Disease of Ordinal Multistages
Hani Samawi, Jingjing Yin, Haresh Rochani, Chen Mo & Jing Kersey
Pages: 552-558
Published online: 09 Feb 2021
AbstractforPost-Test Diagnostic Accuracy Measures of a Continuous Test With a Disease of Ordinal Multistages | Full Text | References | PDF (937.7 KB) | EPUB
  • 80 Views
  • 2 CrossRef citations
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Article
Least Conservative Critical Boundaries of Multiple Hypothesis Testing in a Range of Correlation Values
Jiangtao Gou
Pages: 559-567
Published online: 10 Feb 2021
AbstractforLeast Conservative Critical Boundaries of Multiple Hypothesis Testing in a Range of Correlation Values | Full Text | References | PDF (4.6 MB) | EPUB | Supplemental
  • 208 Views
  • 2 CrossRef citations
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Article
A Bayesian Decision-Theoretic Design for Simultaneous Biomarker-Based Subgroup Selection and Efficacy Evaluation
Zheyu Wang, Fujun Wang, Chenguang Wang, Jianliang Zhang, Hao Wang, Li Shi, Zhuojun Tang & Gary L. Rosner
Pages: 568-579
Published online: 09 Feb 2021
AbstractforA Bayesian Decision-Theoretic Design for Simultaneous Biomarker-Based Subgroup Selection and Efficacy Evaluation | Full Text | References | PDF (1.2 MB) | EPUB
  • 202 Views
  • 1 CrossRef citations
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Article
Dynamic Monitoring of Ongoing Clinical Trials
Tai Xie, Peng Zhang, Weichung Joe Shih, Yue Tu & K. K. Gordon Lan
Pages: 580-591
Published online: 08 Mar 2021
AbstractforDynamic Monitoring of Ongoing Clinical Trials | Full Text | References | PDF (2.1 MB) | EPUB
  • 2634 Views
  • 1 CrossRef citations
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Open Access
Article
Teasing Out the Overall Survival Benefit With Adjustment for Treatment Switching to Multiple Treatments
Yuqing Xu, Meijing Wu, Weili He, Qiming Liao & Yabing Mai
Pages: 592-601
Published online: 18 May 2021
AbstractforTeasing Out the Overall Survival Benefit With Adjustment for Treatment Switching to Multiple Treatments | Full Text | References | PDF (1.5 MB) | EPUB | Supplemental
  • 555 Views
  • 1 CrossRef citations
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Article
On the Implementation of Robust Meta-Analytical-Predictive Prior
Hongtao Zhang, Alan Y Chiang & Mike Branson
Pages: 602-610
Published online: 01 Jun 2021
AbstractforOn the Implementation of Robust Meta-Analytical-Predictive Prior | Full Text | References | PDF (1.1 MB) | EPUB
  • 303 Views
  • 0 CrossRef citations
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Article
Simulation-Based Pharmacokinetics Sampling Design for Evaluating Correlates of Prevention Efficacy of Passive HIV Monoclonal Antibody Prophylaxis
Lily Zhang, Peter B. Gilbert, Edmund Capparelli & Yunda Huang
Pages: 611-625
Published online: 28 Jun 2021
AbstractforSimulation-Based Pharmacokinetics Sampling Design for Evaluating Correlates of Prevention Efficacy of Passive HIV Monoclonal Antibody Prophylaxis | Full Text | References | PDF (4.6 MB) | EPUB
  • 1041 Views
  • 3 CrossRef citations
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Open Access
Article
Bayesian Approaches for Handling Hypothetical Estimands in Longitudinal Clinical Trials With Gaussian Outcomes
G. Frank Liu, Jiajun Liu, Fang Chen, Roee Gutman & Kaifeng Lu
Pages: 626-635
Published online: 18 Jun 2021
AbstractforBayesian Approaches for Handling Hypothetical Estimands in Longitudinal Clinical Trials With Gaussian Outcomes | Full Text | References | PDF (1.3 MB) | EPUB | Supplemental
  • 488 Views
  • 2 CrossRef citations
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Article
Quick Multiple Test Procedures and p-Value Adjustments
Jiangtao Gou
Pages: 636-650
Published online: 12 Jul 2021
AbstractforQuick Multiple Test Procedures and p-Value Adjustments | Full Text | References | PDF (1.7 MB) | EPUB
  • 208 Views
  • 3 CrossRef citations
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Article
Exact Properties of Some Heteroscedastic TOST Alternatives for Bioequivalence
Gwowen Shieh, Show-Li Jan & Cheng-Shiun Leu
Pages: 651-660
Published online: 12 Jul 2021
AbstractforExact Properties of Some Heteroscedastic TOST Alternatives for Bioequivalence | Full Text | References | PDF (1.1 MB) | EPUB | Supplemental
  • 837 Views
  • 0 CrossRef citations
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Open Access
Article
Using Surrogate Endpoints in Adaptive Designs with Delayed Treatment Effect
Qing Li, Jianchang Lin, Mengya Liu, Liwen Wu & Yingying Liu
Pages: 661-670
Published online: 26 Jul 2021
AbstractforUsing Surrogate Endpoints in Adaptive Designs with Delayed Treatment Effect | Full Text | References | PDF (1.6 MB) | EPUB
  • 475 Views
  • 4 CrossRef citations
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