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Statistics in Biopharmaceutical Research Volume 3, 2011 - Issue 3
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Articles

Optimal Sample Sizes and Go/No-Go Decisions for Phase II/III Development Programs Based on Probability of Success

Kaihong Jiang
Pages 463-475 | Received 01 Nov 2010, Published online: 24 Jan 2012

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Ying-Ying Zhang, Teng-Zhong Rong & Man-Man Li. (2022) Eight predictive powers with historical and interim data for futility and efficacy analysis. Statistical Theory and Related Fields 6:4, pages 277-298.
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Bo Huang, Enayet Talukder, Lixin Han & Pei-Fen Kuan. (2019) Quantitative decision-making in randomized Phase II studies with a time-to-event endpoint. Journal of Biopharmaceutical Statistics 29:1, pages 189-202.
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Tony Sabin, James Matcham, Andrew Copas & Mahesh K. B. Parmar. (2015) Assessing End of Phase 2 Decision Criteria. Statistics in Biopharmaceutical Research 7:3, pages 230-237.
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Articles from other publishers (14)

Andrew P. Grieve. (2023) Probability of success and group sequential designs. Pharmaceutical Statistics.
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Ying-Ying Zhang & Qian Ran. (2022) The Imprecision Issues of Four Powers and Eight Predictive Powers with Historical and Interim Data. Mathematics 10:20, pages 3898.
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Annie Stylianou, Keona J H Blanks, Rachel A Gibson, Lindsay K Kendall, Mike English, Sarah Williams, Roshni Mehta, Andrew Clarke, Lynn Kanyuuru, Jalemba Aluvaala & Gary L Darmstadt. (2022) Quantitative decision making for investment in global health intervention trials: Case study of the NEWBORN study on emollient therapy in preterm infants in Kenya. Journal of Global Health 12.
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Lisa V. Hampson, Björn Holzhauer, Björn Bornkamp, Joseph Kahn, Markus R. Lange, Wen‐Lin Luo, Pritibha Singh, Steffen Ballerstedt & Giovanni Della Cioppa. (2021) A New Comprehensive Approach to Assess the Probability of Success of Development Programs Before Pivotal Trials. Clinical Pharmacology & Therapeutics 111:5, pages 1050-1060.
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Ying‐Ying Zhang, Teng‐Zhong Rong & Man‐Man Li. (2020) The contemplated average success probability for normally distributed models with an application to optimal sample sizes selection. Statistics in Medicine 39:23, pages 3173-3183.
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Guanghan (Frank) Liu & Joseph Heyse. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online 1 13 .
Adam Crisp, Sam Miller, Douglas Thompson & Nicky Best. (2018) Practical experiences of adopting assurance as a quantitative framework to support decision making in drug development. Pharmaceutical Statistics 17:4, pages 317-328.
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Meinhard Kieser, Marietta Kirchner, Eva Dölger & Heiko Götte. (2018) Optimal planning of phase II/III programs for clinical trials with multiple endpoints. Pharmaceutical Statistics.
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Marietta Kirchner, Meinhard Kieser, Heiko Götte & Armin Schüler. (2016) Utility-based optimization of phase II/III programs. Statistics in Medicine 35:2, pages 305-316.
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Yijie Zhou, Ruji Yao, Bo Yang & Ramachandran Suresh. 2016. New Developments in Statistical Modeling, Inference and Application. New Developments in Statistical Modeling, Inference and Application 91 105 .
Heiko Götte, Armin Schüler, Marietta Kirchner & Meinhard Kieser. (2015) Sample size planning for phase II trials based on success probabilities for phase III. Pharmaceutical Statistics 14:6, pages 515-524.
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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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Jianliang Zhang & Jenny J. Zhang. (2013) Joint probability of statistical success of multiple phase III trials. Pharmaceutical Statistics 12:6, pages 358-365.
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Thomas P. Ryan. 2013. Sample Size Determination and Power. Sample Size Determination and Power 243 275 .

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