Statistics in Biopharmaceutical Research, Volume 15, Issue 4 (2023)

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Statistics in Biopharmaceutical Research, Volume 15, Issue 4 (2023)

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Selected Articles from the Nonclinical Biostatistics Conference 2021

Introduction
Selected Articles from the Nonclinical Biostatistics Conference 2021
John Kolassa & Eve Pickering
Page: 705
Published online: 08 Nov 2023
CitationforSelected Articles from the Nonclinical Biostatistics Conference 2021 | Full Text | References | PDF (220.5 KB) | EPUB
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Free Access
Article
Sequential Bayes Factors for Sample Size Reduction in Preclinical Experiments with Binary Outcomes
Tony Pourmohamad & Chenguang Wang
Pages: 706-715
Published online: 12 Oct 2022
AbstractforSequential Bayes Factors for Sample Size Reduction in Preclinical Experiments with Binary Outcomes | Full Text | References | PDF (1.4 MB) | EPUB | Supplemental
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Article
A Closer Look at the Kernels Generated by the Decision and Regression Tree Ensembles
Dai Feng & Richard Baumgartner
Pages: 716-725
Published online: 02 Feb 2023
AbstractforA Closer Look at the Kernels Generated by the Decision and Regression Tree Ensembles | Full Text | References | PDF (1.8 MB) | EPUB | Supplemental
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Article
A Novel Approach for Modeling Biphasic Dose–Response Curves
Ya-Ching M. Hsieh, Leon Chang & Alfred M. Barron
Pages: 726-736
Published online: 30 Jun 2023
AbstractforA Novel Approach for Modeling Biphasic Dose–Response Curves | Full Text | References | PDF (2.4 MB) | EPUB | Supplemental
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Research Articles

Article
Qualitative versus Quantitative Treatment-by-Subgroup Interaction in Equivalence Studies with Multiple Subgroups
Wanjie Sun, Don Schuirmann & Stella Grosser
Pages: 737-747
Published online: 31 Oct 2022
AbstractforQualitative versus Quantitative Treatment-by-Subgroup Interaction in Equivalence Studies with Multiple Subgroups | Full Text | References | PDF (1.7 MB) | EPUB
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Article
Consistency Based Multiplicity Adjustment Approach—Multiple Doses in Phase III Studies
Qian H. Li, Qiqi Deng & Naitee Ting
Pages: 748-754
Published online: 31 Oct 2022
AbstractforConsistency Based Multiplicity Adjustment Approach—Multiple Doses in Phase III Studies | Full Text | References | PDF (1.1 MB) | EPUB
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Article
Shrinkage Estimation Methods for Subgroup Analyses
Julian Riehl, Arno Fritsch & Katja Ickstadt
Pages: 755-766
Published online: 01 Dec 2022
AbstractforShrinkage Estimation Methods for Subgroup Analyses | Full Text | References | PDF (1.9 MB) | EPUB | Supplemental
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Article
Comparison of Adverse Event Risks in Randomized Controlled Trials with Varying Follow-Up Times and Competing Events: Results from an Empirical Study
Kaspar Rufibach, Regina Stegherr, Claudia Schmoor, Valentine Jehl, Arthur Allignol, Annette Boeckenhoff, Cornelia Dunger-Baldauf, Lewin Eisele, Thomas Künzel, Katrin Kupas, Friedhelm Leverkus, Matthias Trampisch, Yumin Zhao, Tim Friede, Jan Beyersmann & on behalf of the SAVVY project
Pages: 767-780
Published online: 12 Dec 2022
AbstractforComparison of Adverse Event Risks in Randomized Controlled Trials with Varying Follow-Up Times and Competing Events: Results from an Empirical Study | Full Text | References | PDF (1.8 MB) | EPUB
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Article
A Flexible Analytical Framework for Reference-Based Imputation, Delta Adjustment and Tipping-Point Stress-Testing
Alberto García-Hernandez, Teresa Pérez, María del Carmen Pardo & Dimitris Rizopoulos
Pages: 781-793
Published online: 02 Feb 2023
AbstractforA Flexible Analytical Framework for Reference-Based Imputation, Delta Adjustment and Tipping-Point Stress-Testing | Full Text | References | PDF (1.5 MB) | EPUB | Supplemental
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Article
A Modification of Location Commensurate Power Prior in Clinical Trials
Hong Tran
Pages: 794-801
Published online: 06 Jan 2023
AbstractforA Modification of Location Commensurate Power Prior in Clinical Trials | Full Text | References | PDF (1.3 MB) | EPUB | Supplemental
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Article
The Targeted Virtual Control Approach for Single-Arm Clinical Trials with External Controls
Yixin Fang & Sheng Zhong
Pages: 802-811
Published online: 05 Jan 2023
AbstractforThe Targeted Virtual Control Approach for Single-Arm Clinical Trials with External Controls | Full Text | References | PDF (973.9 KB) | EPUB
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Article
Assessing the Commonly Used Assumptions in Estimating the Principal Causal Effect in Clinical Trials
Yongming Qu, Ilya Lipkovich & Stephen J. Ruberg
Pages: 812-819
Published online: 14 Feb 2023
AbstractforAssessing the Commonly Used Assumptions in Estimating the Principal Causal Effect in Clinical Trials | Full Text | References | PDF (799 KB) | EPUB | Supplemental
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Article
An Expected Score Approach to Ordinal Outcomes in a Bayesian, Response Adaptive, Randomized Trial
Jonathan Beall, Jordan Elm, James Chamberlain, Eric Rosenthal, Jaideep Kapur & Valerie Durkalski-Mauldin
Pages: 820-825
Published online: 24 Feb 2023
AbstractforAn Expected Score Approach to Ordinal Outcomes in a Bayesian, Response Adaptive, Randomized Trial | Full Text | References | PDF (679 KB) | EPUB
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Article
Missing Data Imputation for a Multivariate Outcome of Mixed Variable Types
Tuo Wang, Rachel Zilinskas, Ying Li & Yongming Qu
Pages: 826-837
Published online: 14 Feb 2023
AbstractforMissing Data Imputation for a Multivariate Outcome of Mixed Variable Types | Full Text | References | PDF (2.3 MB) | EPUB
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Article
Modified Simon’s Two-Stage Design for Phase IIA Clinical Trials in Oncology—Dynamic Monitoring and More Flexibility
Weichung Joe Shih, Yunqi Zhao & Tai Xie
Pages: 838-844
Published online: 10 Mar 2023
AbstractforModified Simon’s Two-Stage Design for Phase IIA Clinical Trials in Oncology—Dynamic Monitoring and More Flexibility | Full Text | References | PDF (1.3 MB) | EPUB
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Open Access

Letter to the Editor

Statistical Considerations in Pediatric Cancer Trials: Report of American Statistical Association Biopharmaceutical Section Open Forum Discussions
Rajeshwari Sridhara, Olga Marchenko, Qi Jiang, Elizabeth Barksdale, Todd A. Alonzo, Anup Amatya, David Arons, Alex Bliu, Qiuyi Choo, Michael Coory, Martha Donoghue, Lori Ehrlich, Leonardo Fabio Costa Filho, Elizabeth Fox, Boris Freidlin, Nancy Goodman, Douglas S. Hawkins, Dieter A. Häring, Dominik Karres, E. Anders Kolb, Helen Mao, Pallavi S. Mishra Kalyani, Arlene Naranjo, Alberto Pappo, Martin Posch, Karen Price, Andrew Raven, Khadija Rerhou Rantell, Lindsay Renfro, Donna R. Rivera, Pourab Roy, Minghua Shan, Richard Simon, Sonia Singh, Malcolm Smith, Marc Theoret, Marius Thomas, Zachary Thomas, Andrew Thompson, Hong Tian, Yevgen Tymofyeyev, Jonathon Vallejo, Kyle Wathen, Jingjing Ye, Richard Pazdur & Gregory Reaman
Pages: 845-851
Published online: 25 Jul 2023
AbstractforStatistical Considerations in Pediatric Cancer Trials: Report of American Statistical Association Biopharmaceutical Section Open Forum Discussions | Full Text | References | PDF (881.9 KB) | EPUB
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