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Original Articles

Definitions and statistical properties of master protocols for personalized medicine in oncology

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Pages 217-228 | Received 14 Feb 2017, Published online: 09 Oct 2017

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Tze Leung Lai, Michael Sklar & Nikolas Thomas Weissmueller. (2021) Novel Clinical Trial Designs and Statistical Methods in the Era of Precision Medicine. Statistics in Biopharmaceutical Research 13:2, pages 133-146.
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Karolina Strzebonska, Mateusz Blukacz, Mateusz T. Wasylewski, Maciej Polak, Bishal Gyawali & Marcin Waligora. (2022) Risk and benefit for umbrella trials in oncology: a systematic review and meta-analysis. BMC Medicine 20:1.
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Haiyan Zheng & James M S Wason. (2022) Borrowing of information across patient subgroups in a basket trial based on distributional discrepancy. Biostatistics 23:1, pages 120-135.
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Peter Murphy, Lindsay Claxton, Robert Hodgson, David Glynn, Lucy Beresford, Matthew Walton, Alexis Llewellyn, Stephen Palmer & Sofia Dias. (2021) Exploring Heterogeneity in Histology-Independent Technologies and the Implications for Cost-Effectiveness. Medical Decision Making 41:2, pages 165-178.
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Christian Dittrich, Lutz Edler & Herbert Sindermann. 2020. Kompendium Internistische Onkologie. Kompendium Internistische Onkologie 1 53 .
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Adam C. Palmer, Deborah Plana & Peter K. Sorger. (2020) Comparing the Efficacy of Cancer Therapies between Subgroups in Basket Trials. Cell Systems 11:5, pages 449-460.e2.
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Andrew R. Exley, Khadija Rantell & James McBlane. (2020) Clinical development of cell therapies for cancer: The regulators' perspective. European Journal of Cancer 138, pages 41-53.
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Ming-Wen An, Quyen Duong, Jennifer Le-Rademacher & Sumithra J. Mandrekar. (2020) Principles of Good Clinical Trial Design. Journal of Thoracic Oncology 15:8, pages 1277-1280.
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Elias Laurin Meyer, Peter Mesenbrink, Cornelia Dunger-Baldauf, Hans-Jürgen Fülle, Ekkehard Glimm, Yuhan Li, Martin Posch & Franz König. (2020) The Evolution of Master Protocol Clinical Trial Designs: A Systematic Literature Review. Clinical Therapeutics 42:7, pages 1330-1360.
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Olivier Collignon, Christian Gartner, Anna‐Bettina Haidich, Robert James Hemmings, Benjamin Hofner, Frank Pétavy, Martin Posch, Khadija Rantell, Kit Roes & Anja Schiel. (2020) Current Statistical Considerations and Regulatory Perspectives on the Planning of Confirmatory Basket, Umbrella, and Platform Trials. Clinical Pharmacology & Therapeutics 107:5, pages 1059-1067.
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Andriy Krendyukov & Sreekanth Gattu. (2020) Critical Factors Shaping Strategy Development of an Innovative Medicine in Oncology. Pharmaceutical Medicine 34:2, pages 103-112.
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Sarah P. Blagden, Lucinda Billingham, Louise C. Brown, Sean W. Buckland, Alison M. Cooper, Stephanie Ellis, Wendy Fisher, Helen Hughes, Debbie A. Keatley, Francois M. Maignen, Alex Morozov, Will Navaie, Sarah Pearson, Abeer Shaaban, Kirsty Wydenbach, Pamela R. Kearns, Christiane Abouzeid, Rubina Ahmed, Sue Bailey, Catherine Blewett, Helen Campbell, Maria Antonietta Cerone, Glen Clack, Natalie Cook, Serban Ghiorghiu, Sarah Halford, Andrew Johnston, Rick Kaplan, Anna Lawson, Emma Lowe, Jacqueline Mathews, Ilaria Mirabile, Leeza Osipenko, Dipak Patel, Claire Potter, Aoife Regan, Marivic Ricamara, Carly Ringrose, Joanne Rodger, Gurcharan K. Sandhu, Francesca Schiavone, Julie Silvester, Matthew R. Sydes, Charles Weller & Angeliki Yiangou. (2020) Effective delivery of Complex Innovative Design (CID) cancer trials—A consensus statement. British Journal of Cancer 122:4, pages 473-482.
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Fang-Shu Ou, Ming-Wen An, Amy S. Ruppert & Sumithra J. Mandrekar. (2019) Discussion of Trial Designs for Biomarker Identification and Validation Through the Use of Case Studies. JCO Precision Oncology:3, pages 1-10.
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Karolina Strzebonska & Marcin Waligora. (2019) Umbrella and basket trials in oncology: ethical challenges. BMC Medical Ethics 20:1.
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Jennifer Le-Rademacher, Suzanne Dahlberg, J. Jack Lee, Alex A. Adjei & Sumithra J. Mandrekar. (2018) Biomarker Clinical Trials in Lung Cancer: Design, Logistics, Challenges, and Practical Considerations. Journal of Thoracic Oncology 13:11, pages 1625-1637.
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