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Expert Opinion on Medical Diagnostics Volume 2, 2008 - Issue 6
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Review

Designs and adaptive analysis plans for pivotal clinical trials of therapeutics and companion diagnostics

Richard Simon Chief National Cancer Institute, Biometric Research Branch, 9000 Rockville Pike, Bethesda, MD 20892-7434, USA +1 301 496 0975; +1 301 402 0560; [email protected]
, DSc
Pages 721-729 | Published online: 04 Jun 2008

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Mark Glickman, Xiaofei Wang, Herbert Pang & Todd A. Schwartz. (2009) Here's to Your Health. CHANCE 22:2, pages 55-62.
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Vandana S. Nikam. 2021. Immunotherapy – A Novel Facet of Modern Therapeutics. Immunotherapy – A Novel Facet of Modern Therapeutics 137 152 .
David Machin, Michael J. Campbell, Say Beng Tan & Sze Huey Tan. 2018. Sample Sizes for Clinical, Laboratory and Epidemiology Studies. Sample Sizes for Clinical, Laboratory and Epidemiology Studies 363 380 .
David Machin, Michael J. Campbell, Say Beng Tan & Sze Huey Tan. 2018. Sample Sizes for Clinical, Laboratory and Epidemiology Studies. Sample Sizes for Clinical, Laboratory and Epidemiology Studies 239 250 .
Miranta Antoniou, Ruwanthi Kolamunnage-Dona & Andrea Jorgensen. (2017) Biomarker-Guided Non-Adaptive Trial Designs in Phase II and Phase III: A Methodological Review. Journal of Personalized Medicine 7:1, pages 1.
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Junlong LiLihui ZhaoLu TianTianxi CaiBrian ClaggettAndrea Callegaro, Benjamin Dizier, Bart Spiessens, Fernando Ulloa-Montoya & Lee-Jen Wei. (2016) A predictive enrichment procedure to identify potential responders to a new therapy for randomized, comparative controlled clinical studies. Biometrics 72:3, pages 877-887.
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Miranta Antoniou, Andrea L Jorgensen & Ruwanthi Kolamunnage-Dona. (2016) Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review. PLOS ONE 11:2, pages e0149803.
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Mark R. Trusheim & Ernst R. Berndt. (2015) The clinical benefits, ethics, and economics of stratified medicine and companion diagnostics. Drug Discovery Today 20:12, pages 1439-1450.
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Scott C. Bell, Kris De Boeck & Margarida D. Amaral. (2015) New pharmacological approaches for cystic fibrosis: Promises, progress, pitfalls. Pharmacology & Therapeutics 145, pages 19-34.
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Kewal K. JainKewal K. Jain. 2015. Textbook of Personalized Medicine. Textbook of Personalized Medicine 589 654 .
Parvin Tajik, Aleiko H. Zwinderman, Ben W. Mol & Patrick M. Bossuyt. (2013) Trial Designs for Personalizing Cancer Care: A Systematic Review and Classification. Clinical Cancer Research 19:17, pages 4578-4588.
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Richard Simon. 2013. Genomic and Personalized Medicine. Genomic and Personalized Medicine 237 246 .
Richard Simon. (2012) Clinical trials for predictive medicine. Statistics in Medicine 31:25, pages 3031-3040.
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Douglas E. Feltner & Kenneth R. Evans. 2012. Essential CNS Drug Development. Essential CNS Drug Development 70 91 .
Stella Wanjugu Karuri & Richard Simon. (2012) A two‐stage Bayesian design for co‐development of new drugs and companion diagnostics. Statistics in Medicine 31:10, pages 901-914.
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Stephen L. George & Xiaofei Wang. 2012. Designs for Clinical Trials. Designs for Clinical Trials 157 177 .
Richard Simon. (2010) Clinical trials for predictive medicine: new challenges and paradigms. Clinical Trials 7:5, pages 516-524.
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Richard Simon. (2010) Translational research in oncology: key bottlenecks and new paradigms. Expert Reviews in Molecular Medicine 12.
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Richard Simon. (2010) Moving from correlative science to predictive oncology. EPMA Journal 1:3, pages 377-387.
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Richard Simon. (2010) Clinical trial designs for evaluating the medical utility of prognostic and predictive biomarkers in oncology. Personalized Medicine 7:1, pages 33-47.
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Richard Simon. (2009) Advances in clinical trial designs for predictive biomarker discovery and validation. Current Breast Cancer Reports 1:4, pages 216-221.
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Kewal K. JainKewal K. Jain. 2009. Textbook of Personalized Medicine. Textbook of Personalized Medicine 149 163 .

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