Statistics in Biopharmaceutical Research, Volume 13, Issue 4 (2021)

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Statistics in Biopharmaceutical Research, Volume 13, Issue 4 (2021)

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Editor’s Note

Editorial
Editor’s Note
Toshimitsu Hamasaki
Pages: 375-376
Published online: 27 Sep 2021
CitationforEditor’s Note | Full Text | References | PDF (291.3 KB) | EPUB
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Research Article

Article
Randomization-Based Methods for Treatment Comparisons for Dichotomous Outcomes for Multiple Anatomical Regions
Jing Yu & Gary Koch
Pages: 377-383
Published online: 12 May 2020
AbstractforRandomization-Based Methods for Treatment Comparisons for Dichotomous Outcomes for Multiple Anatomical Regions | Full Text | References | PDF (693.8 KB) | EPUB | Supplemental
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Article
Statistical Inference Based on Accelerated Failure Time Models Under Model Misspecification and Small Samples
Ryota Ishii, Kazushi Maruo, Hisashi Noma & Masahiko Gosho
Pages: 384-394
Published online: 13 May 2020
AbstractforStatistical Inference Based on Accelerated Failure Time Models Under Model Misspecification and Small Samples | Full Text | References | PDF (2 MB) | EPUB | Supplemental
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Article
Sample Size Allocation in Multiregional Dose-Finding Study Using MCP-Mod
Yusuke Yamaguchi & Toshifumi Sugitani
Pages: 395-404
Published online: 13 May 2020
AbstractforSample Size Allocation in Multiregional Dose-Finding Study Using MCP-Mod | Full Text | References | PDF (1.8 MB) | EPUB | Supplemental
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Article
Penalized Logistic Regression Likelihood Ratio Test Analysis to Detect Signals of Adverse Events From Interactions in Postmarket Safety Surveillance
Kijoeng Nam, Nicholas C. Henderson, Patricia Rohan & Estelle Russek-Cohen
Pages: 405-414
Published online: 18 May 2020
AbstractforPenalized Logistic Regression Likelihood Ratio Test Analysis to Detect Signals of Adverse Events From Interactions in Postmarket Safety Surveillance | Full Text | References | PDF (953.2 KB) | EPUB | Supplemental
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Article
An Improved Sample Size Calculation Method for Score Tests in Generalized Linear Models
Yongqiang Tang, Liang Zhu & Jiezhun Gu
Pages: 415-424
Published online: 18 May 2020
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Article
Sample Size Determination for Stratified Phase II Cancer Trials With Monotone Order Constraints
Menghao Xu, Ting Ye, Jun-jun Zhao & Menggang Yu
Pages: 425-434
Published online: 02 Jun 2020
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Article
Sample Size Calculation for “Gold-Standard” Noninferiority Trials With Fixed Margins and Negative Binomial Endpoints
Gosuke Homma & Takashi Daimon
Pages: 435-447
Published online: 08 Jun 2020
AbstractforSample Size Calculation for “Gold-Standard” Noninferiority Trials With Fixed Margins and Negative Binomial Endpoints | Full Text | References | PDF (2.4 MB) | EPUB | Supplemental
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Article
Partial Correlation Coefficient for a Study With Repeated Measurements
Guogen Shan, Ece Bayram, Jessica Z. K. Caldwell, Justin B. Miller, Jay J. Shen & Shawn Gerstenberger
Pages: 448-454
Published online: 20 Jul 2020
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Article
A Reproducibility Rule for Choosing the Number of Imputations When Reporting Clinical Trials
Anders Gorst-Rasmussen
Pages: 455-460
Published online: 21 Jul 2020
AbstractforA Reproducibility Rule for Choosing the Number of Imputations When Reporting Clinical Trials | Full Text | References | PDF (686 KB) | EPUB
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Article
Improving Dose-Finding for New Agents as Monotherapy and Add-On Therapy
Zhen Zeng, Cong Chen, Heng Zhou & Meihua Wang
Pages: 461-467
Published online: 03 Aug 2020
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Article
Appraising Minimum Effect of Standardized Contrasts in ANCOVA Designs: Statistical Power, Sample Size, and Covariate Imbalance Considerations
Gwowen Shieh
Pages: 468-475
Published online: 17 Aug 2020
AbstractforAppraising Minimum Effect of Standardized Contrasts in ANCOVA Designs: Statistical Power, Sample Size, and Covariate Imbalance Considerations | Full Text | References | PDF (818 KB) | EPUB | Supplemental
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Article
Noninferiority Clinical Trials With Binary Outcome: Statistical Methods Used in Practice
Yulia Sidi & Ofer Harel
Pages: 476-482
Published online: 18 Aug 2020
AbstractforNoninferiority Clinical Trials With Binary Outcome: Statistical Methods Used in Practice | Full Text | References | PDF (1 MB) | EPUB
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Article
An Alternative Implementation of Reference-Based Controlled Imputation Procedures
Kaifeng Lu
Pages: 483-491
Published online: 18 Aug 2020
AbstractforAn Alternative Implementation of Reference-Based Controlled Imputation Procedures | Full Text | References | PDF (1.1 MB) | EPUB | Supplemental
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Article
Sample Size Determination in Group-Sequential Trials Assessing Interim Futility by Intermediate Composite Endpoints
Shogo Nomura
Pages: 492-503
Published online: 24 Aug 2020
AbstractforSample Size Determination in Group-Sequential Trials Assessing Interim Futility by Intermediate Composite Endpoints | Full Text | References | PDF (1 MB) | EPUB
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Article
Use of Weighted Performance Goals in Prospective Single-Arm Clinical Studies Designed to Assess the Safety and Effectiveness of Medical Devices
Nelson Lu, Heng Li & Yun-Ling Xu
Pages: 504-507
Published online: 24 Aug 2020
AbstractforUse of Weighted Performance Goals in Prospective Single-Arm Clinical Studies Designed to Assess the Safety and Effectiveness of Medical Devices | Full Text | References | PDF (495.3 KB) | EPUB | Supplemental
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Letter to the Editor

Letter
On Identification of the Principal Stratum Effect in Patients Who Would Comply If Treated
Oliver Dukes, Kelly Van Lancker, Björn Bornkamp, Dominik Heinzmann, Kaspar Rufibach & Marcel Wolbers
Pages: 508-510
Published online: 09 Feb 2021
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Letter
Rejoinder to Letter to the Editor on “A New Principal Stratum Estimand Investigating the Treatment Effect in Patients Who Would Comply, If Treated With a Specific Treatment”
Klaus Groes Larsen & Mette Krog Josiassen
Pages: 511-512
Published online: 21 Oct 2021
CitationforRejoinder to Letter to the Editor on “A New Principal Stratum Estimand Investigating the Treatment Effect in Patients Who Would Comply, If Treated With a Specific Treatment” | Full Text | References | PDF (321.5 KB) | EPUB
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