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Original Articles

Decision Rules for Subgroup Selection Based on a Predictive Biomarker

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Pages 188-202 | Received 07 Dec 2012, Accepted 26 Sep 2013, Published online: 06 Jan 2014

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Zheyu Wang, Fujun Wang, Chenguang Wang, Jianliang Zhang, Hao Wang, Li Shi, Zhuojun Tang & Gary L. Rosner. (2022) A Bayesian Decision-Theoretic Design for Simultaneous Biomarker-Based Subgroup Selection and Efficacy Evaluation. Statistics in Biopharmaceutical Research 14:4, pages 568-579.
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Ryuji Uozumi & Chikuma Hamada. (2020) Utility-Based Interim Decision Rule Planning in Adaptive Population Selection Designs With Survival Endpoints. Statistics in Biopharmaceutical Research 12:3, pages 360-368.
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Laura Benner & Meinhard Kieser. (2018) Timing of the interim analysis in adaptive enrichment designs. Journal of Biopharmaceutical Statistics 28:4, pages 622-632.
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Johannes Krisam & Meinhard Kieser. (2017) Optimal Interim Decision Rules Based on a Binary Surrogate Outcome for Adaptive Biomarker-Based Trials in Oncology. Statistics in Biopharmaceutical Research 9:4, pages 321-332.
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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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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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Tony Sabin, James Matcham, Andrew Copas & Mahesh K. B. Parmar. (2015) Assessing End of Phase 2 Decision Criteria. Statistics in Biopharmaceutical Research 7:3, pages 230-237.
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Articles from other publishers (14)

Beibo Zhao, Anastasia Ivanova & Jason Fine. (2023) Inference on subgroups identified based on a heterogeneous treatment effect in a post hoc analysis of a clinical trial. Clinical Trials 20:4, pages 370-379.
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Yong Lin, Weichung J. Shih & Shou‐En Lu. (2019) Two‐stage enrichment clinical trial design with adjustment for misclassification in predictive biomarkers. Statistics in Medicine 38:29, pages 5445-5469.
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Thomas Ondra, Sebastian Jobjörnsson, Robert A Beckman, Carl-Fredrik Burman, Franz König, Nigel Stallard & Martin Posch. (2017) Optimized adaptive enrichment designs. Statistical Methods in Medical Research 28:7, pages 2096-2111.
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Toshifumi Sugitani, Martin Posch, Frank Bretz & Franz Koenig. (2018) Flexible alpha allocation strategies for confirmatory adaptive enrichment clinical trials with a prespecified subgroup. Statistics in Medicine 37:24, pages 3387-3402.
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Shu-Chih Su, Xiaoming Li, Yanli Zhao & Ivan S. F. Chan. (2017) Population-Enrichment Adaptive Design Strategy for an Event-Driven Vaccine Efficacy Trial. Statistics in Biosciences 10:2, pages 357-370.
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Prema Nedungadi, Akshay Iyer, Georg Gutjahr, Jasmine Bhaskar & Asha B. Pillai. (2018) Data-Driven Methods for Advancing Precision Oncology. Current Pharmacology Reports 4:2, pages 145-156.
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Kevin Kunzmann, Laura Benner & Meinhard Kieser. (2017) Point estimation in adaptive enrichment designs. Statistics in Medicine 36:25, pages 3935-3947.
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Julien Tanniou, Ingeborg van der Tweel, Steven Teerenstra & Kit C. B. Roes. (2016) Subgroup analyses in confirmatory clinical trials: time to be specific about their purposes. BMC Medical Research Methodology 16:1.
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Thomas Ondra, Sebastian Jobjörnsson, Robert A. Beckman, Carl-Fredrik Burman, Franz König, Nigel Stallard & Martin Posch. (2016) Optimizing Trial Designs for Targeted Therapies. PLOS ONE 11:9, pages e0163726.
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Shoichi Ohwada & Satoshi Morita. (2016) Bayesian adaptive patient enrollment restriction to identify a sensitive subpopulation using a continuous biomarker in a randomized phase 2 trial. Pharmaceutical Statistics 15:5, pages 420-429.
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Johannes Krisam & Meinhard Kieser. (2015) Performance of Biomarker-Based Subgroup Selection Rules in Adaptive Enrichment Designs. Statistics in Biosciences 8:1, pages 8-27.
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Gernot Wassmer & Werner BrannathGernot Wassmer & Werner Brannath. 2016. Group Sequential and Confirmatory Adaptive Designs in Clinical Trials. Group Sequential and Confirmatory Adaptive Designs in Clinical Trials 241 276 .
Ekkehard Glimm & Lilla Di Scala. (2015) An approach to confirmatory testing of subpopulations in clinical trials. Biometrical Journal 57:5, pages 897-913.
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Johannes Krisam & Meinhard Kieser. (2015) Optimal Decision Rules for Biomarker-Based Subgroup Selection for a Targeted Therapy in Oncology. International Journal of Molecular Sciences 16:12, pages 10354-10375.
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