Journal of Biopharmaceutical Statistics, Volume 26, Issue 1 (2016)

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Journal of Biopharmaceutical Statistics, Volume 26, Issue 1 (2016)

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Trends and innovations in clinical trial statistics

Guest Editorial

Trends and innovations in clinical trial statistics
Olga Marchenko & Alex Dmitrienko
Pages: 1-2
Published online: 20 Jan 2016
CitationforTrends and innovations in clinical trial statistics | Full Text | PDF (134.6 KB)
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Free Access

Articles

Article
Statistical innovations in the medical device world sparked by the FDA
Gregory Campbell & Lilly Q. Yue
Pages: 3-16
Published online: 20 Jan 2016
AbstractforStatistical innovations in the medical device world sparked by the FDA | Full Text | References | PDF (1,005.4 KB)
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Article
The role of quantitative safety evaluation in regulatory decision making of drugs
Aloka G. Chakravarty, Rima Izem, Stephine Keeton, Clara Y. Kim, Mark S. Levenson & Mat Soukup
Pages: 17-29
Published online: 20 Jan 2016
AbstractforThe role of quantitative safety evaluation in regulatory decision making of drugs | Full Text | References | PDF (983.8 KB)
  • 532 Views
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Article
Missing data in clinical trials for weight management
Bradley W. McEvoy
Pages: 30-36
Published online: 20 Jan 2016
AbstractforMissing data in clinical trials for weight management | Full Text | References | PDF (531 KB)
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Article
Statistical challenges in a regulatory review of cardiovascular and CNS clinical trials
H. M. James Hung, Sue-Jane Wang, Peiling Yang, Kun Jin, John Lawrence, George Kordzakhia & Tristan Massie
Pages: 37-43
Published online: 20 Jan 2016
AbstractforStatistical challenges in a regulatory review of cardiovascular and CNS clinical trials | Full Text | References | PDF (528.2 KB)
  • 369 Views
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Article
On sample size estimation and re-estimation adjusting for variability in confirmatory trials
Pei-Shien Wu, Min Lin & Shein-Chung Chow
Pages: 44-54
Published online: 20 Jan 2016
AbstractforOn sample size estimation and re-estimation adjusting for variability in confirmatory trials | Full Text | References | PDF (789.2 KB)
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Article
Making what’s advanced today routine tomorrow
Stephen J. Ruberg
Pages: 55-70
Published online: 20 Jan 2016
AbstractforMaking what’s advanced today routine tomorrow | Full Text | References | PDF (1.1 MB)
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Article
General guidance on exploratory and confirmatory subgroup analysis in late-stage clinical trials
Alex Dmitrienko, Christoph Muysers, Arno Fritsch & Ilya Lipkovich
Pages: 71-98
Published online: 20 Jan 2016
AbstractforGeneral guidance on exploratory and confirmatory subgroup analysis in late-stage clinical trials | Full Text | References | PDF (1.8 MB)
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Article
Methods for identification and confirmation of targeted subgroups in clinical trials: A systematic review
Thomas Ondra, Alex Dmitrienko, Tim Friede, Alexandra Graf, Frank Miller, Nigel Stallard & Martin Posch
Pages: 99-119
Published online: 20 Jan 2016
AbstractforMethods for identification and confirmation of targeted subgroups in clinical trials: A systematic review | Full Text | References | PDF (1.8 MB)
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Open Access
Article
Tradeoff-based optimization criteria in clinical trials with multiple objectives and adaptive designs
Alex Dmitrienko, Gautier Paux, Erik Pulkstenis & Jianliang Zhang
Pages: 120-140
Published online: 20 Jan 2016
AbstractforTradeoff-based optimization criteria in clinical trials with multiple objectives and adaptive designs | Full Text | References | PDF (1.4 MB)
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Article
Nine-year change in statistical design, profile, and success rates of Phase II oncology trials
Anastasia Ivanova, Barry Paul, Olga Marchenko, Guochen Song, Neerali Patel & Stergios J. Moschos
Pages: 141-149
Published online: 20 Jan 2016
AbstractforNine-year change in statistical design, profile, and success rates of Phase II oncology trials | Full Text | References | PDF (655 KB)
  • 482 Views
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Article
Practical designs for Phase I combination studies in oncology
Nolan A. Wages, Anastasia Ivanova & Olga Marchenko
Pages: 150-166
Published online: 20 Jan 2016
AbstractforPractical designs for Phase I combination studies in oncology | Full Text | References | PDF (1.2 MB)
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Article
Can sequential parallel comparison design and two-way enriched design be useful in medical device clinical trials?
Anastasia Ivanova, Zhiwei Zhang, Laura Thompson, Ying Yang, Richard M. Kotz & Xin Fang
Pages: 167-177
Published online: 20 Jan 2016
AbstractforCan sequential parallel comparison design and two-way enriched design be useful in medical device clinical trials? | Full Text | References | PDF (860.1 KB)
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Article
Some thoughts on drug interchangeability
Shein-Chung Chow, Fuyu Song & Meng Chen
Pages: 178-186
Published online: 20 Jan 2016
AbstractforSome thoughts on drug interchangeability | Full Text | References | PDF (658.1 KB)
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Book Reviews

Book Review
Data Analysis with Competing Risks and Intermediate States, edited by Ronald B. Geskus
Boca Raton, FL, Chapman and Hall/CRC, 2015, 277 pp., $80, ISBN: 9781466570351
Sally Wilkes
Pages: 187-188
Published online: 20 Jan 2016
CitationforData Analysis with Competing Risks and Intermediate States, edited by Ronald B. Geskus | Full Text | References | PDF (212.4 KB)
  • 161 Views
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Book Review
Design and analysis of clinical trials for predictive medicine, edited by Shigeyuki Matsui, Mark Buyse, and Richard Simon
Chapman and Hall/CRC, 400 pp., $100, ISBN 9781466558151
Arunava Chakravartty
Pages: 189-190
Published online: 20 Jan 2016
CitationforDesign and analysis of clinical trials for predictive medicine, edited by Shigeyuki Matsui, Mark Buyse, and Richard Simon | Full Text | PDF (208.9 KB)
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