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Journal of Biopharmaceutical Statistics Volume 28, 2018 - Issue 2: Special Issue: Precision Medicine in Cancer Research
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Original Articles

On Enrichment Strategies for Biomarker Stratified Clinical Trials

Xiaofei WangDepartment of Biostatistics and Bioinformatics, Duke University, Durham, NC, U.S.A.Correspondence[email protected]
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,
Jingzhu ZhouDepartment of Biostatistics and Bioinformatics, Duke University, Durham, NC, U.S.A.View further author information
,
Ting WangDepartment of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, U.S.A.View further author information
&
Stephen L GeorgeDepartment of Biostatistics and Bioinformatics, Duke University, Durham, NC, U.S.A.View further author information
Pages 292-308 | Received 16 Mar 2017, Accepted 07 Sep 2017, Published online: 30 Oct 2017

Citations (13)

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Fang Xia, Stephen L. George, Jing Ning, Liang Li & Xuelin Huang. (2021) A signature enrichment design with Bayesian adaptive randomization. Journal of Applied Statistics 48:6, pages 1091-1110.
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Ting Wang, Xiaofei Wang, Stephen L George & Haibo Zhou. (2020) Design and analysis of biomarker-integrated clinical trials with adaptive threshold detection and flexible patient enrichment. Journal of Biopharmaceutical Statistics 30:6, pages 1060-1076.
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Articles from other publishers (11)

Ravi Bansal, David J. Hellerstein, Siddhant Sawardekar, Ying Chen & Bradley S. Peterson. (2023) A randomized controlled trial of desvenlafaxine-induced structural brain changes in the treatment of persistent depressive disorder. Psychiatry Research: Neuroimaging 331, pages 111634.
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Valentin Vinnat, Jean-Daniel Chiche, Alexandre Demoule & Sylvie Chevret. (2023) Simulation study for evaluating an adaptive-randomisation Bayesian hybrid trial design with enrichment. Contemporary Clinical Trials Communications 33, pages 101141.
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Jeffrey S. BarrettJeffrey S. Barrett. 2022. Fundamentals of Drug Development. Fundamentals of Drug Development 149 168 .
Songchang Shi, Shuo Wei, Xiaobin Pan, Lihui Zhang, Shujuan Zhang, Xincai Wang, Songjing Shi & Wei Lin. (2022) Identification of early biomarkers of transcriptomics in alveolar macrophage for the prognosis of intubated ARDS patients. BMC Pulmonary Medicine 22:1.
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Oliver Ingo Hoffmann, Manuel Regenauer, Bastian Czogalla, Christine Brambs, Alexander Burges & Barbara Mayer. (2022) Interpatient Heterogeneity in Drug Response and Protein Biomarker Expression of Recurrent Ovarian Cancer. Cancers 14:9, pages 2279.
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Jamie E. Chaft, Yu Shyr, Boris Sepesi & Patrick M. Forde. (2022) Preoperative and Postoperative Systemic Therapy for Operable Non–Small-Cell Lung Cancer. Journal of Clinical Oncology 40:6, pages 546-555.
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Wen Jing Sim, Kian Chung Lee & Jean Paul Thiery. 2022. Biomarkers of the Tumor Microenvironment. Biomarkers of the Tumor Microenvironment 563 580 .
Xiaofei Wang, Steven Piantadosi, Jennifer Le-Rademacher & Sumithra J. Mandrekar. (2021) Statistical Considerations for Subgroup Analyses. Journal of Thoracic Oncology 16:3, pages 375-380.
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Luciano J. Costa, Benjamin A. Derman, Susan Bal, Surbhi Sidana, Saurabh Chhabra, Rebecca Silbermann, Jing C. Ye, Gordon Cook, Robert F. Cornell, Sarah A. Holstein, Qian Shi, James Omel, Natalie S. Callander, Wee Joo Chng, Vania Hungria, Angelo Maiolino, Edward Stadtmauer, Sergio Giralt, Marcelo Pasquini, Andrzej J. Jakubowiak, Gareth J. Morgan, Amrita Krishnan, Graham H. Jackson, Mohamad Mohty, Maria Victoria Mateos, Meletious A. Dimopoulos, Thierry Facon, Andrew Spencer, Jesus San Miguel, Parameswaran Hari, Saad Z. Usmani, Salomon Manier, Phillip McCarthy, Shaji Kumar, Francesca Gay & Bruno Paiva. (2020) International harmonization in performing and reporting minimal residual disease assessment in multiple myeloma trials. Leukemia 35:1, pages 18-30.
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Xiaofei Wang, Jianwen Cai & Stephen L. George. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online 1 14 .
Ting Wang, Xiaofei Wang, Haibo Zhou, Jianwen Cai & Stephen L. George. (2018) Auxiliary variable–enriched biomarker‐stratified design. Statistics in Medicine 37:30, pages 4610-4635.
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