Statistics in Biopharmaceutical Research, Volume 12, Issue 4 (2020)

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Statistics in Biopharmaceutical Research, Volume 12, Issue 4 (2020)

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Special Issue on COVID-19

Editorial
Statistical Challenges in the Conduct and Management of Ongoing Clinical Trials During the COVID-19 Pandemic
Toshimitsu Hamasaki, Frank Bretz, Freda Cooner, Lisa M. LaVange & Martin Posch
Pages: 397-398
Published online: 28 Oct 2020
CitationforStatistical Challenges in the Conduct and Management of Ongoing Clinical Trials During the COVID-19 Pandemic | Full Text | References | PDF (416.1 KB) | EPUB
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Article
Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic
R. Daniel Meyer, Bohdana Ratitch, Marcel Wolbers, Olga Marchenko, Hui Quan, Daniel Li, Christine Fletcher, Xin Li, David Wright, Yue Shentu, Stefan Englert, Wei Shen, Jyotirmoy Dey, Thomas Liu, Ming Zhou, Norman Bohidar, Peng-Liang Zhao & Michael Hale
Pages: 399-411
Published online: 06 Jul 2020
AbstractforStatistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic | Full Text | References | PDF (1.1 MB) | EPUB | Supplemental
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Article
Comment on “Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic”
Sylva H. Collins & Mark S. Levenson
Pages: 412-413
Published online: 06 Jul 2020
CitationforComment on “Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic” | Full Text | References | PDF (280.3 KB) | EPUB
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Article
Under a Black Cloud Glimpsing a Silver Lining: Comment on Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic
Rob Hemmings
Pages: 414-418
Published online: 14 Jul 2020
First Page PreviewforUnder a Black Cloud Glimpsing a Silver Lining: Comment on Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic | Full Text | References | PDF (501.1 KB) | EPUB
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Article
Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials
Mouna Akacha, Janice Branson, Frank Bretz, Bharani Dharan, Paul Gallo, Insa Gathmann, Robert Hemmings, Julie Jones, Dong Xi & Emmanuel Zuber
Pages: 419-426
Published online: 17 Aug 2020
AbstractforChallenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials | Full Text | References | PDF (1.7 MB) | EPUB | Supplemental
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Article
Assessing the Impact of COVID-19 on the Clinical Trial Objective and Analysis of Oncology Clinical Trials—Application of the Estimand Framework
Evgeny Degtyarev, Kaspar Rufibach, Yue Shentu, Godwin Yung, Michelle Casey, Stefan Englert, Feng Liu, Yi Liu, Oliver Sailer, Jonathan Siegel, Steven Sun, Rui Tang, Jiangxiu Zhou & on behalf of the Industry Working Group on Estimands in Oncology
Pages: 427-437
Published online: 14 Jul 2020
AbstractforAssessing the Impact of COVID-19 on the Clinical Trial Objective and Analysis of Oncology Clinical Trials—Application of the Estimand Framework | Full Text | References | PDF (1.3 MB) | EPUB
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Article
Operational Experiences in China and Statistical Issues on the Conduct of Clinical Trials During the COVID-19 Pandemic
Tong Guo, Chian Chen, Chieh Chiang, Chi-Tian Chen & Chin-Fu Hsiao
Pages: 438-442
Published online: 18 Aug 2020
AbstractforOperational Experiences in China and Statistical Issues on the Conduct of Clinical Trials During the COVID-19 Pandemic | Full Text | References | PDF (533 KB) | EPUB
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Article
The Impact of Major Events on Ongoing Noninferiority Trials, With Application to COVID-19
Brian L. Wiens & Ilya Lipkovich
Pages: 443-450
Published online: 05 Aug 2020
AbstractforThe Impact of Major Events on Ongoing Noninferiority Trials, With Application to COVID-19 | Full Text | References | PDF (737.7 KB) | EPUB
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Article
Assessing via Simulation the Operating Characteristics of the WHO Scale for COVID-19 Endpoints
Michael O’Kelly & Siying Li
Pages: 451-460
Published online: 01 Oct 2020
AbstractforAssessing via Simulation the Operating Characteristics of the WHO Scale for COVID-19 Endpoints | Full Text | References | PDF (1.5 MB) | EPUB | Supplemental
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Article
Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue?
Cornelia Ursula Kunz, Silke Jörgens, Frank Bretz, Nigel Stallard, Kelly Van Lancker, Dong Xi, Sarah Zohar, Christoph Gerlinger & Tim Friede
Pages: 461-477
Published online: 19 Aug 2020
AbstractforClinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue? | Full Text | References | PDF (2 MB) | EPUB
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Article
Embedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience
Pierre-François Dequin, Amélie Le Gouge, Elsa Tavernier, Bruno Giraudeau & Sarah Zohar
Pages: 478-482
Published online: 19 Aug 2020
AbstractforEmbedding a COVID-19 group sequential clinical trial within an ongoing trial: lessons from an unusual experience | Full Text | References | PDF (618.1 KB) | EPUB | Supplemental
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Article
Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19
Nigel Stallard, Lisa Hampson, Norbert Benda, Werner Brannath, Thomas Burnett, Tim Friede, Peter K. Kimani, Franz Koenig, Johannes Krisam, Pavel Mozgunov, Martin Posch, James Wason, Gernot Wassmer, John Whitehead, S. Faye Williamson, Sarah Zohar & Thomas Jaki
Pages: 483-497
Published online: 29 Jul 2020
AbstractforEfficient Adaptive Designs for Clinical Trials of Interventions for COVID-19 | Full Text | References | PDF (1.6 MB) | EPUB
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Article
Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19
Mary Nilsson, Brenda Crowe, Greg Anglin, Greg Ball, Melvin Munsaka, Seta Shahin & Wei Wang
Pages: 498-505
Published online: 08 Sep 2020
AbstractforClinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19 | Full Text | References | PDF (744.8 KB) | EPUB
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Article
Machine learning for clinical trials in the era of COVID-19
William R. Zame, Ioana Bica, Cong Shen, Alicia Curth, Hyun-Suk Lee, Stuart Bailey, James Weatherall, David Wright, Frank Bretz & Mihaela van der Schaar
Pages: 506-517
Published online: 18 Aug 2020
AbstractforMachine learning for clinical trials in the era of COVID-19 | Full Text | References | PDF (1.3 MB) | EPUB
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Letter to the Editor

Letter
The Hazards of Period Specific and Weighted Hazard Ratios
Jonathan W. Bartlett, Tim P. Morris, Mats J. Stensrud, Rhian M. Daniel, Stijn K. Vansteelandt & Carl-Fredrik Burman
Pages: 518-519
Published online: 23 Jun 2020
CitationforThe Hazards of Period Specific and Weighted Hazard Ratios | Full Text | References | PDF (294 KB) | EPUB
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Letter
Rejoinder to Letter to the Editor “The Hazards of Period Specific and Weighted Hazard Ratios”
Ray S. Lin, Ji Lin, Satrajit Roychoudhury, Keaven M. Anderson, Tianle Hu, Bo Huang, Larry F. Leon, Jason J. Z. Liao, Rong Liu, Xiaodong Luo, Pralay Mukhopadhyay, Rui Qin, Kay Tatsuoka, Xuejing Wang, Yang Wang, Jian Zhu, Tai-Tsang Chen, Renee Iacona & Cross-Pharma Non-Proportional Hazards Working Group
Pages: 520-521
Published online: 28 Oct 2020
CitationforRejoinder to Letter to the Editor “The Hazards of Period Specific and Weighted Hazard Ratios” | Full Text | References | PDF (300.8 KB) | EPUB
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