Journal of Biopharmaceutical Statistics, Volume 30, Issue 6 (2020)

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Journal of Biopharmaceutical Statistics, Volume 30, Issue 6 (2020)

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Innovative Design and Analysis of Complex Clinical Trials

Research Article

Article
Guest editors’note on the special issue innovative design and analysis of complex clinical trials
Anastasia Ivanova & Yuan Ji
Page: 947
Published online: 16 Sep 2020
CitationforGuest editors’note on the special issue innovative design and analysis of complex clinical trials | Full Text | PDF (179.9 KB) | EPUB
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Article
Dose-finding design and benchmark for a right censored endpoint
Anaïs Andrillon, Sylvie Chevret, Shing M Lee & Lucie Biard
Pages: 948-963
Published online: 23 Nov 2020
AbstractforDose-finding design and benchmark for a right censored endpoint | Full Text | References | PDF (680.7 KB) | EPUB | Supplemental
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Research article

Article
Continual reassessment method with regularization in phase I clinical trials
Xiang Li, Anastasia Ivanova, Hong Tian, Pilar Lim & Kevin Liu
Pages: 964-978
Published online: 14 Sep 2020
AbstractforContinual reassessment method with regularization in phase I clinical trials | Full Text | References | PDF (788.9 KB) | EPUB
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Research Article

Article
TEPI-2 and UBI: designs for optimal immuno-oncology and cell therapy dose finding with toxicity and efficacy
Pin Li, Rachael Liu, Jianchang Lin & Yuan Ji
Pages: 979-992
Published online: 20 Sep 2020
AbstractforTEPI-2 and UBI: designs for optimal immuno-oncology and cell therapy dose finding with toxicity and efficacy | Full Text | References | PDF (1.4 MB) | EPUB
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Article
The Joint i3+3 (Ji3+3) design for phase I/II adoptive cell therapy clinical trials
Xiaolei Lin & Yuan Ji
Pages: 993-1005
Published online: 22 Nov 2020
AbstractforThe Joint i3+3 (Ji3+3) design for phase I/II adoptive cell therapy clinical trials | Full Text | References | PDF (2.6 MB) | EPUB | Supplemental
  • 505 Views
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Article
Checkerboard: a Bayesian efficacy and toxicity interval design for phase I/II dose-finding trials
Jun Yin & Ying Yuan
Pages: 1006-1025
Published online: 23 Sep 2020
AbstractforCheckerboard: a Bayesian efficacy and toxicity interval design for phase I/II dose-finding trials | Full Text | References | PDF (5.1 MB) | EPUB
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Article
The precision interventions for severe and/or exacerbation-prone asthma (PrecISE) adaptive platform trial: statistical considerations
Anastasia Ivanova, Elliot Israel, Lisa M. LaVange, Michael C. Peters, Loren C. Denlinger, Wendy C. Moore, Leonard B. Bacharier, M. Alison Marquis, Nathan M. Gotman, Michael R. Kosorok, Chalmer Tomlinson, David T. Mauger, Steve N. Georas, Rosalind J. Wright, Patricia Noel, Gary L. Rosner, Praveen Akuthota, Dean Billheimer, Eugene R. Bleecker, Juan Carlos Cardet, Mario Castro, Emily A. DiMango, Serpil C. Erzurum, John V. Fahy, Merritt L. Fajt, Benjamin M. Gaston, Fernando Holguin, Sonia Jain, Nicholas J. Kenyon, Jerry A. Krishnan, Monica Kraft, Rajesh Kumar, Mark C. Liu, Ngoc P. Ly, James N. Moy, Wanda Phipatanakul, Kristie Ross, Lewis J. Smith, Stanley J. Szefler, W. Gerald Teague, Michael E. Wechsler, Sally E. Wenzel & Steven R. White
Pages: 1026-1037
Published online: 17 Sep 2020
AbstractforThe precision interventions for severe and/or exacerbation-prone asthma (PrecISE) adaptive platform trial: statistical considerations | Full Text | References | PDF (468.2 KB) | EPUB
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Article
Multi-stage adaptive enrichment trial design with subgroup estimation
Neha Joshi, Crystal Nguyen & Anastasia Ivanova
Pages: 1038-1049
Published online: 18 Oct 2020
AbstractforMulti-stage adaptive enrichment trial design with subgroup estimation | Full Text | References | PDF (1.6 MB) | EPUB
  • 382 Views
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Article
Futility stopping in clinical trials, optimality and practical considerations
Yen Chang, Tianhao Song, Jane Monaco & Anastasia Ivanova
Pages: 1050-1059
Published online: 14 Sep 2020
AbstractforFutility stopping in clinical trials, optimality and practical considerations | Full Text | References | PDF (485.5 KB) | EPUB
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Article
Design and analysis of biomarker-integrated clinical trials with adaptive threshold detection and flexible patient enrichment
Ting Wang, Xiaofei Wang, Stephen L George & Haibo Zhou
Pages: 1060-1076
Published online: 11 Nov 2020
AbstractforDesign and analysis of biomarker-integrated clinical trials with adaptive threshold detection and flexible patient enrichment | Full Text | References | PDF (1.1 MB) | EPUB
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Article
Multiplicity issues for platform trials with a shared control arm
Xiaofei Bai, Qiqi Deng & Dacheng Liu
Pages: 1077-1090
Published online: 29 Sep 2020
AbstractforMultiplicity issues for platform trials with a shared control arm | Full Text | References | PDF (3.1 MB) | EPUB
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Article
A BAYESIAN ADAPTIVE TWO-STAGE DESIGN FOR PEDIATRIC CLINICAL TRIALS
Matthew A. Psioda & Xiaoqiang Xue
Pages: 1091-1108
Published online: 05 Oct 2020
AbstractforA BAYESIAN ADAPTIVE TWO-STAGE DESIGN FOR PEDIATRIC CLINICAL TRIALS | Full Text | References | PDF (1.6 MB) | EPUB | Supplemental
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Article
Sample size determination for Bayesian analysis of small n sequential, multiple assignment, randomized trials (snSMARTs) with three agents
Boxian Wei, Thomas M. Braun, Roy N. Tamura & Kelley Kidwell
Pages: 1109-1120
Published online: 06 Sep 2020
AbstractforSample size determination for Bayesian analysis of small n sequential, multiple assignment, randomized trials (snSMARTs) with three agents | Full Text | References | PDF (523.4 KB) | EPUB
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Article
Power calculations for the sequential parallel comparison design with continuous outcomes
Anastasia Ivanova & Bahjat Qaqish
Pages: 1121-1129
Published online: 29 Sep 2020
AbstractforPower calculations for the sequential parallel comparison design with continuous outcomes | Full Text | References | PDF (475.7 KB) | EPUB
  • 160 Views
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Article
Statistical and practical considerations in designing of immuno-oncology trials
Pralay Mukhopadhyay, Wenmei Huang, Paul Metcalfe, Fredrik Öhrn, Mary Jenner & Andrew Stone
Pages: 1130-1146
Published online: 10 Sep 2020
AbstractforStatistical and practical considerations in designing of immuno-oncology trials | Full Text | References | PDF (1.7 MB) | EPUB
  • 3462 Views
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Open Access
Article
Enhancing clarity of clinical trial safety reports for data monitoring committees
Sonia M. Thomas, Kwanhye Jung, Hengrui Sun, Matthew A. Psioda, Pedro Miguel Quibrera & Stephen M. Strakowski
Pages: 1147-1161
Published online: 08 Sep 2020
AbstractforEnhancing clarity of clinical trial safety reports for data monitoring committees | Full Text | References | PDF (2.7 MB) | EPUB
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Open Access

Other

REFEREES FOR VOLUME 28
Pages: i-vii
Published online: 12 Mar 2021
First Page PreviewforREFEREES FOR VOLUME 28 | Full Text | PDF (110.6 KB) | EPUB
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