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Journal of Biopharmaceutical Statistics Volume 23, 2013 - Issue 5
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Original Articles

Randomized Two-Stage Phase II Clinical Trial Designs Based on Barnard's Exact Test

Guogen Shan Department of Environmental and Occupational Health, Epidemiology and Biostatistics Program, University of Nevada Las Vegas, Las Vegas, Nevada, USACorrespondence[email protected]
,
Changxing Ma Department of Biostatistics, University at Buffalo, Buffalo, New York, USA
,
Alan D. Hutson Department of Biostatistics, University at Buffalo, Buffalo, New York, USA
&
Gregory E. Wilding Department of Biostatistics, University at Buffalo, Buffalo, New York, USA
Pages 1081-1090 | Received 10 Apr 2012, Accepted 29 May 2012, Published online: 19 Aug 2013

Citations (31)

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Read on this site (11)

Guogen Shan. (2023) Response adaptive randomization design for a two-stage study with binary response. Journal of Biopharmaceutical Statistics 33:5, pages 575-585.
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Radhakanta Das. (2023) An optimal sequential design in ethical allocation with an adaptive interim analysis. Journal of Nonparametric Statistics 0:0, pages 1-26.
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Radhakanta Das. (2022) An optimal design in a two-stage ethical allocation based on U-statistics. Journal of Statistical Computation and Simulation 92:8, pages 1763-1780.
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Guogen Shan. (2022) Randomized two-stage optimal design for interval-censored data. Journal of Biopharmaceutical Statistics 32:2, pages 298-307.
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Guogen Shan. (2020) Two-stage optimal designs based on exact variance for a single-arm trial with survival endpoints. Journal of Biopharmaceutical Statistics 30:5, pages 797-805.
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Guogen Shan, Alan Hutson, Gregory E Wilding, Changxing Ma & Guo-Liang Tian. (2019) Efficient statistical inference for a parallel study with missing data by using an exact method. Journal of Biopharmaceutical Statistics 29:3, pages 478-490.
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Chia-Min Chen, Yunchan Chi & Hsing-Ming Chang. (2018) Curtailed two-stage design for comparing two arms in randomized phase II clinical trials. Journal of Biopharmaceutical Statistics 28:5, pages 939-950.
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Guogen Shan. (2018) Exact confidence limits for the probability of response in two-stage designs. Statistics 52:5, pages 1086-1095.
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Guogen Shan & John J. Chen. (2018) Optimal inference for Simon's two-stage design with over or under enrollment at the second stage. Communications in Statistics - Simulation and Computation 47:4, pages 1157-1167.
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Guogen Shan, Le Kang, Min Xiao, Hua Zhang & Tao Jiang. (2018) Accurate unconditional p-values for a two-arm study with binary endpoints. Journal of Statistical Computation and Simulation 88:6, pages 1200-1210.
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Uttam Bandyopadhyay & Radhakanta Das. (2017) A comparison between two treatments in a clinical trial with an ethical allocation design. Journal of Statistical Computation and Simulation 87:17, pages 3377-3397.
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Articles from other publishers (20)

Natalie DelRocco, Yipeng Wang, Dongyuan Wu, Yuting Yang & Guogen Shan. (2022) New Confidence Intervals for Relative Risk of Two Correlated Proportions. Statistics in Biosciences 15:1, pages 1-30.
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Kristopher Attwood, Soyun Park & Alan D. Hutson. (2021) Practical and robust test for comparing binomial proportions in the randomized phase II setting . Pharmaceutical Statistics 21:2, pages 361-371.
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Katarina Buganova, Maria Luskova, Jozef Kubas, Michal Brutovsky & Jaroslav Slepecky. (2021) Sustainability of Business through Project Risk Identification with Use of Expert Estimates. Sustainability 13:11, pages 6311.
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Guogen Shan, Charles Bernick, Jessica Z. K. Caldwell & Aaron Ritter. (2021) Machine learning methods to predict amyloid positivity using domain scores from cognitive tests. Scientific Reports 11:1.
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Guogen Shan. (2021) Optimal two-stage designs based on restricted mean survival time for a single-arm study. Contemporary Clinical Trials Communications 21, pages 100732.
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Martin Law, Michael J. Grayling & Adrian P. Mander. (2020) A stochastically curtailed two‐arm randomised phase II trial design for binary outcomes . Pharmaceutical Statistics 20:2, pages 212-228.
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Tao Jiang, Baixin Cao & Guogen Shan. (2020) Accurate confidence intervals for risk difference in meta-analysis with rare events. BMC Medical Research Methodology 20:1.
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Haolun Shi, Teng Zhang & Guosheng Yin. (2020) START: single‐to‐double arm transition design for phase II clinical trials. Pharmaceutical Statistics 19:4, pages 454-467.
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Basavarajaiah D. M.Bhamidipati Narasimha MurthyBasavarajaiah D. M.Bhamidipati Narasimha Murthy. 2020. Design of Experiments and Advanced Statistical Techniques in Clinical Research. Design of Experiments and Advanced Statistical Techniques in Clinical Research 77 131 .
Diletta Colette Invernizzi, Giorgio Locatelli & Naomi J. Brookes. (2019) An exploration of the relationship between nuclear decommissioning projects characteristics and cost performance. Progress in Nuclear Energy 110, pages 129-141.
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Guogen Shan & Alan Hutson. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online 1 8 .
Guogen Shan, Sarah Banks, Justin B. Miller, Aaron Ritter, Charles Bernick, Joseph Lombardo & Jeffrey L. Cummings. (2018) Statistical advances in clinical trials and clinical research. Alzheimer's & Dementia: Translational Research & Clinical Interventions 4:1, pages 366-371.
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Guogen Shan, Hua Zhang & Tao Jiang. (2017) Efficient confidence limits for adaptive one-arm two-stage clinical trials with binary endpoints. BMC Medical Research Methodology 17:1.
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Guogen Shan, Gregory E. Wilding & Alan D. Hutson. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online 1 7 .
Martin F. J. Perescis, Natasja de Bruin, Liesbeth Heijink, Chris Kruse, Lyudmila Vinogradova, Annika Lüttjohann, Gilles van Luijtelaar & Clementina M. van Rijn. (2017) Cannabinoid antagonist SLV326 induces convulsive seizures and changes in the interictal EEG in rats. PLOS ONE 12:2, pages e0165363.
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Guogen ShanGregory E. WildingAlan D. HutsonShawn Gerstenberger. (2015) Optimal adaptive two‐stage designs for early phase II clinical trials. Statistics in Medicine 35:8, pages 1257-1266.
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. 2016. Exact Statistical Inference for Categorical Data. Exact Statistical Inference for Categorical Data 47 48 .
. 2016. Exact Statistical Inference for Categorical Data. Exact Statistical Inference for Categorical Data 49 54 .
Matteo Cellamare & Valeria Sambucini. (2015) A randomized two-stage design for phase II clinical trials based on a Bayesian predictive approach. Statistics in Medicine 34:6, pages 1059-1078.
Crossref
Guogen Shan. (2014) New Nonparametric Rank-Based Tests for Paired Data. Open Journal of Statistics 04:07, pages 495-503.
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