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Journal of Biopharmaceutical Statistics Volume 23, 2013 - Issue 2
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Original Articles

Evaluation of Early Efficacy Endpoints for Proof-of-Concept Trials

Cong Chen Merck & Co., Inc., North Wales, Pennsylvania, USACorrespondence[email protected]
,
Linda Sun Merck & Co., Inc., North Wales, Pennsylvania, USA
&
Chih-Lin Li Department of Statistics, Ohio State University, Columbus, Ohio, USA
Pages 413-424 | Received 02 Aug 2010, Accepted 16 Jul 2011, Published online: 25 Feb 2013

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Xiaofei Bai & Qiqi Deng. (2023) Incorporating Intermediate Endpoint in Two-Stage Design Decision Making. Statistics in Biopharmaceutical Research 15:3, pages 510-518.
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Zhuqing Liu, Jingyi Liu & Meng Xia. (2023) A Bayesian three-tier quantitative decision-making framework for single arm studies in early phase oncology. Journal of Biopharmaceutical Statistics 33:1, pages 60-76.
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Stig Johan Wiklund. (2021) Do strict decision criteria hamper productivity in the pharmaceutical industry?. Journal of Biopharmaceutical Statistics 31:6, pages 788-808.
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Linda Z. Sun, Wen Li, Cong Chen & Jing Zhao. (2020) Advanced Utilization of Intermediate Endpoints for Making Optimized Cost-Effective Decisions in Seamless Phase II/III Oncology Trials. Statistics in Biopharmaceutical Research 12:2, pages 224-233.
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Cong Chen, Xiaoyun (Nicole) Li, Shuai Yuan, Zoran Antonijevic, Rasika Kalamegham & Robert A. Beckman. (2016) Statistical Design and Considerations of a Phase 3 Basket Trial for Simultaneous Investigation of Multiple Tumor Types in One Study. Statistics in Biopharmaceutical Research 8:3, pages 248-257.
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Antti Jekunen. (2014) Decision-making in product portfolios of pharmaceutical research and development – managing streams of innovation in highly regulated markets. Drug Design, Development and Therapy 8, pages 2009-2016.
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Articles from other publishers (20)

Cong Chen, Linda Sun & Xuekui Zhang. (2023) A promising biomarker adaptive Phase 2/3 design – Explained and expanded. Contemporary Clinical Trials Communications 36, pages 101229.
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Weidong Zhang, Sunhee Ro, Qi Jiang, Xiaoyun Li, Rong Liu, Chengxing ‘Cindy’ Lu, Olga Marchenko, Jing Zhao & Zhenzhen Xu. (2022) Statistical and Operational Considerations for 2-Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker-Selected Populations in Oncology Confirmatory Trials. Therapeutic Innovation & Regulatory Science 56:4, pages 552-560.
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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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Li Fan, Jing Zhao & Wen Li. (2020) The extension of 2-in-1 adaptive phase 2/3 designs and its application in oncology clinical trials. Contemporary Clinical Trials 98, pages 106148.
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Thomas Jemielita, Archie Tse & Cong Chen. (2019) Oncology phase II proof‐of‐concept studies with multiple targets: Randomized controlled trial or single arm?. Pharmaceutical Statistics 19:2, pages 117-125.
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Wen Li, Jing Zhao, Xiaoyun Li, Cong Chen & Robert A. Beckman. (2019) Multi‐stage enrichment and basket trial designs with population selection. Statistics in Medicine 38:29, pages 5470-5485.
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Claudia M. Campbell, Ian Gilron, Tina Doshi & Srinivasa Raja. (2019) Designing and conducting proof-of-concept chronic pain analgesic clinical trials. PAIN Reports 4:3, pages e697.
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Honghui Zhou & Diane R. MouldJeremiah D. Momper, Andrew Mulberg, Nitin Mehrotra, Dan Turner, William Faubion, Laurie Conklin, Karim Azer & Marla C. Dubinsky. 2019. Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases. Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases 315 336 .
Cong Chen, Xiaoyun (Nicole) Li, Wen Li & Robert A. Beckman. (2018) Adaptive expansion of biomarker populations in phase 3 clinical trials. Contemporary Clinical Trials 71, pages 181-185.
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Xiaoyun Li, Cong Chen & Wen Li. (2016) Adaptive Biomarker Population Selection in Phase III Confirmatory Trials with Time-to-Event Endpoints. Statistics in Biosciences 10:2, pages 324-341.
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Cong Chen, Keaven Anderson, Devan V. Mehrotra, Eric H. Rubin & Archie Tse. (2018) A 2-in-1 adaptive phase 2/3 design for expedited oncology drug development. Contemporary Clinical Trials 64, pages 238-242.
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Cong Chen, Wen Li, Xiaoyun (Nicole) Li & Robert A. Beckman. 2018. Biopharmaceutical Applied Statistics Symposium. Biopharmaceutical Applied Statistics Symposium 53 64 .
Wen Li, Cong ChenXiaoyun LiRobert A. Beckman. (2017) Estimation of treatment effect in two-stage confirmatory oncology trials of personalized medicines. Statistics in Medicine.
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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. 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 .
Robert A. Beckman & Cong Chen. 2015. Optimization of Pharmaceutical R&D Programs and Portfolios. Optimization of Pharmaceutical R&D Programs and Portfolios 155 180 .
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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