Statistics in Biopharmaceutical Research, Volume 16, Issue 2 (2024)

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Statistics in Biopharmaceutical Research, Volume 16, Issue 2 (2024)

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The NISS Special Series: The NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions

Article
Coping with Information Loss and the Use of Auxiliary Sources of Data: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions
Silvia Calderazzo, Sergey Tarima, Carissa Reid, Nancy Flournoy, Tim Friede, Nancy Geller, James L Rosenberger, Nigel Stallard, Moreno Ursino, Marc Vandemeulebroecke, Kelly Van Lancker & Sarah Zohar
Pages: 141-157
Published online: 26 Jun 2023
AbstractforCoping with Information Loss and the Use of Auxiliary Sources of Data: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions | Full Text | References | PDF (2.8 MB) | EPUB
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Research Articles

Article
Vaccine Development during a Pandemic: General Lessons for Clinical Trial Design
Benjamin Hofner, Elina Asikanius, Wolfgang Jacquet, Theodor Framke, Katrien Oude Rengerink, Lukas Aguirre Dávila, Maria Grünewald, Florian Klinglmüller, Martin Posch, Finbarr P. Leacy, Thomas Lang, Armin Koch, Jörg Zinserling & Kit Roesextra
Pages: 158-170
Published online: 28 Jun 2023
AbstractforVaccine Development during a Pandemic: General Lessons for Clinical Trial Design | Full Text | References | PDF (2.1 MB) | EPUB | Supplemental
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Open Access
Article
A Bayesian Adaptive Umbrella Trial Design with Robust Information Borrowing for Screening Multiple Combination Therapies
Qing Liu, Wenxi Yu, Leiwen Gao, Xun Jiang, Michael Wolf & May Mo
Pages: 171-181
Published online: 26 Jun 2023
AbstractforA Bayesian Adaptive Umbrella Trial Design with Robust Information Borrowing for Screening Multiple Combination Therapies | Full Text | References | PDF (1.2 MB) | EPUB | Supplemental
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Article
A Propensity-Score Integrated Approach to Bayesian Dynamic Power Prior Borrowing
Jixian Wang, Hongtao Zhang & Ram Tiwari
Pages: 182-191
Published online: 11 Jul 2023
AbstractforA Propensity-Score Integrated Approach to Bayesian Dynamic Power Prior Borrowing | Full Text | References | PDF (5.7 MB) | EPUB
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Article
Properties of a Confirmatory Two-Stage Adaptive Procedure for Assessing Average Bioequivalence
Marie Louise Østerdal, Kyle Raymond & Christian Bressen Pipper
Pages: 192-204
Published online: 11 Jul 2023
AbstractforProperties of a Confirmatory Two-Stage Adaptive Procedure for Assessing Average Bioequivalence | Full Text | References | PDF (1.2 MB) | EPUB
  • 93 Views
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Article
A Comparison of Randomization Methods for Multi-Arm Clinical Trials
Ruqayya A. Azher, James M. S. Wason & Michael J. Grayling
Pages: 205-217
Published online: 29 Aug 2023
AbstractforA Comparison of Randomization Methods for Multi-Arm Clinical Trials | Full Text | References | PDF (2.9 MB) | EPUB | Supplemental
  • 1120 Views
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Open Access
Article
A Case Study of 2-Stage Seamless Adaptive Sample Size Re-Estimation Design with Efficacy Interim Analysis When Slope Is the Primary Endpoint
Qi Zhang, Yuqian Shen, Hui Quan, Pascal Minini & Lin Wang
Pages: 218-228
Published online: 13 Sep 2023
AbstractforA Case Study of 2-Stage Seamless Adaptive Sample Size Re-Estimation Design with Efficacy Interim Analysis When Slope Is the Primary Endpoint | Full Text | References | PDF (1.6 MB) | EPUB | Supplemental
  • 130 Views
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Article
Enhancement of Basket Trial Designs with Incorporation of a Bayesian Three-Outcome Decision-Making Framework
Gu Mi, Yue Yang, Zhumengmeng Jin, Ji Lin & Christelle Lorenzato
Pages: 229-240
Published online: 13 Sep 2023
AbstractforEnhancement of Basket Trial Designs with Incorporation of a Bayesian Three-Outcome Decision-Making Framework | Full Text | References | PDF (1.4 MB) | EPUB | Supplemental
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Article
Modified Robust Meta-Analytic-Predictive Priors for Incorporating Historical Controls in Clinical Trials
Qiang Zhao & Haijun Ma
Pages: 241-247
Published online: 15 Sep 2023
AbstractforModified Robust Meta-Analytic-Predictive Priors for Incorporating Historical Controls in Clinical Trials | Full Text | References | PDF (1.1 MB) | EPUB | Supplemental
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Article
A Note on Stratification Errors in the Analysis of Clinical Trials
Neal Thomas
Pages: 248-256
Published online: 20 Sep 2023
AbstractforA Note on Stratification Errors in the Analysis of Clinical Trials | Full Text | References | PDF (815.9 KB) | EPUB
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Article
Estimands in Real-World Evidence Studies
Jie Chen, Daniel Scharfstein, Hongwei Wang, Binbing Yu, Yang Song, Weili He, John Scott, Xiwu Lin & Hana Lee
Pages: 257-269
Published online: 10 Nov 2023
AbstractforEstimands in Real-World Evidence Studies | Full Text | References | PDF (1.5 MB) | EPUB
  • 309 Views
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Article
Deep Neural Networks Guided Ensemble Learning for Point Estimation
Tianyu Zhan, Haoda Fu & Jian Kang
Pages: 270-278
Published online: 20 Oct 2023
AbstractforDeep Neural Networks Guided Ensemble Learning for Point Estimation | Full Text | References | PDF (1.3 MB) | EPUB | Supplemental
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