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Journal of Biopharmaceutical Statistics Volume 24, 2014 - Issue 1: Subgroup Analysis in Clinical Trials
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Original Articles

Adaptive Designs for Confirmatory Clinical Trials with Subgroup Selection

Nigel Stallard Warwick Medical School, University of Warwick, Coventry, United KingdomCorrespondence[email protected]
,
Thomas Hamborg Warwick Medical School, University of Warwick, Coventry, United Kingdom
,
Nicholas Parsons Warwick Medical School, University of Warwick, Coventry, United Kingdom
&
Tim Friede Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany
Pages 168-187 | Received 11 Jul 2013, Accepted 23 Aug 2013, Published online: 06 Jan 2014

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Liwen Wu, Qing Li, Mengya Liu & Jianchang Lin. (2022) Incorporating Surrogate Information for Adaptive Subgroup Enrichment Design with Sample Size Re-Estimation. Statistics in Biopharmaceutical Research 14:4, pages 493-504.
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Fanni Natanegara, Névine Zariffa, Joan Buenconsejo, Freda Cooner, Divya Lakshminarayanan, Samiran Ghosh, Jerald S. Schindler & Margaret Gamalo. (2022) Statistical Opportunities to Accelerate Development for COVID-19 Therapeutics. Statistics in Biopharmaceutical Research 14:1, pages 5-21.
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Cornelia Ursula Kunz, Silke Jörgens, Frank Bretz, Nigel Stallard, Kelly Van Lancker, Dong Xi, Sarah Zohar, Christoph Gerlinger & Tim Friede. (2020) Clinical Trials Impacted by the COVID-19 Pandemic: Adaptive Designs to the Rescue?. Statistics in Biopharmaceutical Research 12:4, pages 461-477.
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Ryuji Uozumi & Chikuma Hamada. (2017) Interim decision-making strategies in adaptive designs for population selection using time-to-event endpoints. Journal of Biopharmaceutical Statistics 27:1, pages 84-100.
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Thomas Ondra, Alex Dmitrienko, Tim Friede, Alexandra Graf, Frank Miller, Nigel Stallard & Martin Posch. (2016) Methods for identification and confirmation of targeted subgroups in clinical trials: A systematic review. Journal of Biopharmaceutical Statistics 26:1, pages 99-119.
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Alex Dmitrienko, Christoph Muysers, Arno Fritsch & Ilya Lipkovich. (2016) General guidance on exploratory and confirmatory subgroup analysis in late-stage clinical trials. Journal of Biopharmaceutical Statistics 26:1, pages 71-98.
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Heiko Götte, Margarita Donica & Giacomo Mordenti. (2015) Improving Probabilities of Correct Interim Decision in Population Enrichment Designs. Journal of Biopharmaceutical Statistics 25:5, pages 1020-1038.
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Gernot Wassmer & Vlad Dragalin. (2015) Designing Issues in Confirmatory Adaptive Population Enrichment Trials. Journal of Biopharmaceutical Statistics 25:4, pages 651-669.
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Stephen J. Ruberg & Lei Shen. (2015) Personalized Medicine: Four Perspectives of Tailored Medicine. Statistics in Biopharmaceutical Research 7:3, pages 214-229.
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