Journal of Biopharmaceutical Statistics, Volume 22, Issue 4 (2012)

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Journal of Biopharmaceutical Statistics, Volume 22, Issue 4 (2012)

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Adaptive Designs for Clinical Trials: Considerations about and Beyond the FDA Adaptive Designs Guidance

Miscellany

Note on Special Technical Issue on Adaptive Designs for Clinical Trials
Qing Liu & Mark Chang
Pages: 615-616
Published online: 31 May 2012
CitationforNote on Special Technical Issue on Adaptive Designs for Clinical Trials | Full Text | PDF (47.7 KB)
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Original Articles

Article
On Efficient Two-Stage Adaptive Designs for Clinical Trials with Sample Size Adjustment
Qing Liu, Gang Li, Keaven M. Anderson & Pilar Lim
Pages: 617-640
Published online: 31 May 2012
AbstractforOn Efficient Two-Stage Adaptive Designs for Clinical Trials with Sample Size Adjustment | Full Text | References | PDF (169.8 KB)
  • 491 Views
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Article
Optimization of Adaptive Designs: Efficiency Evaluation
Sandeep Menon & Mark Chang
Pages: 641-661
Published online: 31 May 2012
AbstractforOptimization of Adaptive Designs: Efficiency Evaluation | Full Text | References | PDF (674.1 KB)
  • 319 Views
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Article
Adaptive Group Sequential Test with Changing Patient Population
Huaibao Feng & Qing Liu
Pages: 662-678
Published online: 31 May 2012
AbstractforAdaptive Group Sequential Test with Changing Patient Population | Full Text | References | PDF (186.8 KB)
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Article
Sample Size Adaptation in Fixed-Dose Combination Drug Trial
H. M. James Hung & Sue-Jane Wang
Pages: 679-686
Published online: 31 May 2012
AbstractforSample Size Adaptation in Fixed-Dose Combination Drug Trial | Full Text | References | PDF (202.7 KB)
  • 240 Views
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Article
On Adaptive Error Spending Approach for Group Sequential Trials with Random Information Levels
Qing Liu, Pilar Lim, Issac Nuamah & Yulan Li
Pages: 687-699
Published online: 31 May 2012
AbstractforOn Adaptive Error Spending Approach for Group Sequential Trials with Random Information Levels | Full Text | References | PDF (129.5 KB)
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Article
Estimation of Treatment Effect Following a Clinical Trial with Adaptive Design
Xiaolong Luo, Mingyu Li, Weichung Joe Shih & Peter Ouyang
Pages: 700-718
Published online: 31 May 2012
AbstractforEstimation of Treatment Effect Following a Clinical Trial with Adaptive Design | Full Text | References | PDF (153.5 KB)
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Article
Adaptive Randomization for Clinical Trials
William F. Rosenberger, Oleksandr Sverdlov & Feifang Hu
Pages: 719-736
Published online: 31 May 2012
AbstractforAdaptive Randomization for Clinical Trials | Full Text | References | PDF (199.7 KB)
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Article
Doubly Randomized Delayed-Start Design for Enrichment Studies with Responders or Nonresponders
Qing Liu, Pilar Lim, Jaskaran Singh, David Lewin, Barry Schwab & Justine Kent
Pages: 737-757
Published online: 31 May 2012
AbstractforDoubly Randomized Delayed-Start Design for Enrichment Studies with Responders or Nonresponders | Full Text | References | PDF (151 KB)
  • 422 Views
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Article
Flexible Analytical Methods for Adding a Treatment Arm Mid-Study to an Ongoing Clinical Trial
Jordan J. Elm, Yuko Y. Palesch, Gary G. Koch, Vanessa Hinson, Bernard Ravina & Wenle Zhao
Pages: 758-772
Published online: 31 May 2012
AbstractforFlexible Analytical Methods for Adding a Treatment Arm Mid-Study to an Ongoing Clinical Trial | Full Text | References | PDF (133.6 KB)
  • 274 Views
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Article
Analysis of Time-to-Event Data with Nonuniform Patient Entry and Loss to Follow-Up under a Two-Stage Seamless Adaptive Design with Weibull Distribution
Qingshu Lu, Siu-Keung Tse, Shein-Chung Chow & Min Lin
Pages: 773-784
Published online: 31 May 2012
AbstractforAnalysis of Time-to-Event Data with Nonuniform Patient Entry and Loss to Follow-Up under a Two-Stage Seamless Adaptive Design with Weibull Distribution | Full Text | References | PDF (117.4 KB)
  • 245 Views
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Article
Adaptive Randomization to Improve Utility-Based Dose-Finding with Bivariate Ordinal Outcomes
Peter F. Thall & Hoang Q. Nguyen
Pages: 785-801
Published online: 31 May 2012
AbstractforAdaptive Randomization to Improve Utility-Based Dose-Finding with Bivariate Ordinal Outcomes | Full Text | References | PDF (378.5 KB)
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Article
A Two-Dimensional Search Algorithm for Dose-Finding Trials of Two Agents
Bee Leng Lee & Shenghua Kelly Fan
Pages: 802-818
Published online: 31 May 2012
AbstractforA Two-Dimensional Search Algorithm for Dose-Finding Trials of Two Agents | Full Text | References | PDF (786 KB)
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Article
Sample Size Estimation in Single-Arm Clinical Trials with Multiple Testing Under Frequentist and Bayesian Approaches
Boris G. Zaslavsky & John Scott
Pages: 819-835
Published online: 31 May 2012
AbstractforSample Size Estimation in Single-Arm Clinical Trials with Multiple Testing Under Frequentist and Bayesian Approaches | Full Text | References | PDF (150.8 KB)
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Article
Minimizing the Maximum Expected Sample Size in Two-Stage Phase II Clinical Trials with Continuous Outcomes
James M. S. Wason & Adrian P. Mander
Pages: 836-852
Published online: 31 May 2012
AbstractforMinimizing the Maximum Expected Sample Size in Two-Stage Phase II Clinical Trials with Continuous Outcomes | Full Text | References | PDF (448.1 KB)
  • 1284 Views
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Open Access
Article
On the Independence of Data Monitoring Committee in Adaptive Design Clinical Trials
Shein-Chung Chow, Ralph Corey & Min Lin
Pages: 853-867
Published online: 31 May 2012
AbstractforOn the Independence of Data Monitoring Committee in Adaptive Design Clinical Trials | Full Text | References | PDF (280.2 KB)
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BOOK REVIEW

Book Review
A Review of: “An Insider's Guide to Clinical Trials, by C. L. Meinert”
New York: Oxford University Press, 2011, ISBN 978-0-19-974296-7, xiii + 279 pp., $39.95.
Kevin McCague
Pages: 868-869
Published online: 31 May 2012
CitationforA Review of: “An Insider's Guide to Clinical Trials, by C. L. Meinert” | Full Text | PDF (50.8 KB)
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Book Review
A Review of: “Understanding Biostatistics, by A. Källén”
Chichester, UK: Wiley, 2011, ISBN 978-0-470-66636-4, xii + 375 pp., $90.
Kaushik Ghosh
Pages: 870-871
Published online: 31 May 2012
CitationforA Review of: “Understanding Biostatistics, by A. Källén” | Full Text | PDF (48.7 KB)
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Book Review
A Review of: “Biostatistical Methods: The Assessment of Relative Risks, second edition, by J. M. Lachin”
Hoboken, NJ: Wiley, 2011, ISBN 978-0-470-50822-0, xxiii + 622 pp., $130.
Sunil K. Dhar
Pages: 872-873
Published online: 31 May 2012
CitationforA Review of: “Biostatistical Methods: The Assessment of Relative Risks, second edition, by J. M. Lachin” | Full Text | PDF (54.8 KB)
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