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Original Articles

Optimal Cost-Effective Designs of Phase II Proof of Concept Trials and Associated Go–No Go Decisions

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Pages 424-436 | Published online: 21 Apr 2009

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Cong Chen, Heng Zhou, Wen Li & Robert A. Beckman. (2021) How Many Cohorts Should Be Considered in an Exploratory Master Protocol?. Statistics in Biopharmaceutical Research 13:3, pages 280-285.
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Cong Chen, Linda Sun & Chih-Lin Li. (2013) Evaluation of Early Efficacy Endpoints for Proof-of-Concept Trials. Journal of Biopharmaceutical Statistics 23:2, pages 413-424.
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Raymond A. Huml, Deborah Collyar, Zoran Antonijevic, Robert A. Beckman, Ruben G. W. Quek & Jingjing Ye. (2023) Aiding the Adoption of Master Protocols by Optimizing Patient Engagement. Therapeutic Innovation & Regulatory Science 57:6, pages 1136-1147.
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Bradley P Carlin & Fabrice Nollevaux. (2022) Bayesian Complex Innovative Trial Designs (CIDs) and Their Use in Drug Development for Rare Disease. The Journal of Clinical Pharmacology 62:S2.
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Robert A. Beckman, Zoran Antonijevic, Mercedeh Ghadessi, Heng Xu, Cong Chen, Yi Liu & Rui Tang. (2022) Innovations in Clinical Development in Rare Diseases of Children and Adults: Small Populations and/or Small Patients. Pediatric Drugs 24:6, pages 657-669.
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Faith M. Gunning, Joaquin A. Anguera, Lindsay W. Victoria & Patricia A. Areán. (2021) A digital intervention targeting cognitive control network dysfunction in middle age and older adults with major depression. Translational Psychiatry 11:1.
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Linchen He, Linqiu Du, Zoran Antonijevic, Martin Posch, Valeriy R Korostyshevskiy & Robert A Beckman. (2020) Efficient two-stage sequential arrays of proof of concept studies for pharmaceutical portfolios. Statistical Methods in Medical Research 30:2, pages 396-410.
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Christy Chuang-Stein & Simon KirbyChristy Chuang-Stein & Simon Kirby. 2021. Quantitative Decisions in Drug Development. Quantitative Decisions in Drug Development 177 196 .
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Siew Wan Hee, Nicholas Parsons & Nigel Stallard. (2017) Decision‐theoretic designs for a series of trials with correlated treatment effects using the Sarmanov multivariate beta‐binomial distribution. Biometrical Journal 60:2, pages 232-245.
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Cong Chen, Qiqi Deng, Linchen He, Devan V. Mehrotra, Eric H. Rubin & Robert A. Beckman. (2017) How many tumor indications should be initially screened in development of next generation immunotherapies?. Contemporary Clinical Trials 59, pages 113-117.
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Christy Chuang-Stein & Simon KirbyChristy Chuang-Stein & Simon Kirby. 2017. Quantitative Decisions in Drug Development. Quantitative Decisions in Drug Development 153 172 .
MR Trusheim, AA Shrier, Z Antonijevic, RA Beckman, RK Campbell, C Chen, KT Flaherty, J Loewy, D Lacombe, S Madhavan, HP Selker & LJ Esserman. (2016) PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms. Clinical Pharmacology & Therapeutics 100:6, pages 713-729.
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Zoran Antonijevic. (2016) The Impact of Adaptive Design on Portfolio Optimization. Therapeutic Innovation & Regulatory Science 50:5, pages 615-619.
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Siew Wan Hee, Thomas Hamborg, Simon Day, Jason Madan, Frank Miller, Martin Posch, Sarah Zohar & Nigel Stallard. (2015) Decision-theoretic designs for small trials and pilot studies: A review. Statistical Methods in Medical Research 25:3, pages 1022-1038.
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Robert A Beckman & Cong Chen. (2015) Translating predictive biomarkers within oncology clinical development programs. Biomarkers in Medicine 9:9, pages 851-862.
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Meihua Wang, G. Frank Liu & Jerald Schindler. (2015) Evaluation of program success for programs with multiple trials in binary outcomes. Pharmaceutical Statistics 14:3, pages 172-179.
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Robert A. Beckman & Cong Chen. 2015. Advances in Cancer Biomarkers. Advances in Cancer Biomarkers 81 90 .
Cong Chen, Robert A. Beckman & Linda Z. Sun. 2015. Optimization of Pharmaceutical R&D Programs and Portfolios. Optimization of Pharmaceutical R&D Programs and Portfolios 141 154 .
Nitin R. Patel & Suresh Ankolekar. 2015. Optimization of Pharmaceutical R&D Programs and Portfolios. Optimization of Pharmaceutical R&D Programs and Portfolios 181 200 .
Robert A. Beckman & Cong Chen. 2015. Optimization of Pharmaceutical R&D Programs and Portfolios. Optimization of Pharmaceutical R&D Programs and Portfolios 155 180 .
Zoran Antonijevic. 2015. Optimization of Pharmaceutical R&D Programs and Portfolios. Optimization of Pharmaceutical R&D Programs and Portfolios 3 16 .
Sarah R. Brown, Walter M. Gregory, Chris Twelves & Julia Brown. 2014. A Practical Guide to Designing Phase II Trials in Oncology. A Practical Guide to Designing Phase II Trials in Oncology 213 225 .
Cong Chen & Robert A. Beckman. (2014) Maximizing Return on Socioeconomic Investment in Phase II Proof-of-Concept Trials. Clinical Cancer Research 20:7, pages 1730-1734.
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Cong Chen, Robert A. Beckman & Linda Z. Sun. 2014. Practical Considerations for Adaptive Trial Design and Implementation. Practical Considerations for Adaptive Trial Design and Implementation 91 113 .
Thomas R. Vetter, Nataliya V. Ivankova, Lee A. Goeddel, Gerald McGwinJr.Jr. & Jean-Francois Pittet. (2013) An Analysis of Methodologies That Can Be Used to Validate if a Perioperative Surgical Home Improves the Patient-centeredness, Evidence-based Practice, Quality, Safety, and Value of Patient Care. Anesthesiology 119:6, pages 1261-1274.
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Nitin R. PatelSuresh Ankolekar, Zoran AntonijevicNatasa Rajicic. (2013) A mathematical model for maximizing the value of phase 3 drug development portfolios incorporating budget constraints and risk. Statistics in Medicine 32:10, pages 1763-1777.
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Nitin Patel, James Bolognese, Christy Chuang-Stein, David Hewitt, Arnold Gammaitoni & Jose Pinheiro. (2012) Designing Phase 2 Trials Based on Program-Level Considerations: A Case Study for Neuropathic Pain. Drug Information Journal 46:4, pages 439-454.
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Robert A. Beckman, Jason Clark & Cong Chen. (2011) Integrating predictive biomarkers and classifiers into oncology clinical development programmes. Nature Reviews Drug Discovery 10:10, pages 735-748.
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