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Journal of Biopharmaceutical Statistics Volume 23, 2013 - Issue 5
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Original Articles

Decision Making from Phase II to Phase III and the Probability of Success: Reassured by “Assurance”?

Kevin J. Carroll Independent Statistical Consultant, Cheshire, United KingdomCorrespondence[email protected]
Pages 1188-1200 | Received 29 Nov 2012, Accepted 19 Mar 2013, Published online: 19 Aug 2013

Citations (19)

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Read on this site (5)

Charles C. Liu & Ron Xiaolong Yu. (2023) Epistemic uncertainty in Bayesian predictive probabilities. Journal of Biopharmaceutical Statistics 0:0, pages 1-19.
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Kenneth G. Kowalski. (2019) Integration of Pharmacometric and Statistical Analyses Using Clinical Trial Simulations to Enhance Quantitative Decision Making in Clinical Drug Development. Statistics in Biopharmaceutical Research 11:1, pages 85-103.
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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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Kenneth G. Kowalski. (2015) My Career as a Pharmacometrician and Commentary on the Overlap Between Statistics and Pharmacometrics in Drug Development. Statistics in Biopharmaceutical Research 7:2, pages 148-159.
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Articles from other publishers (14)

Olivier Collignon. (2023) Can neurofilament lightchain as endpoint in Phase 2 derisk clinical disability worsening in Phase 3 in multiple sclerosis?. Multiple Sclerosis and Related Disorders 80, pages 105078.
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Susanna Gentile & Valeria Sambucini. (2023) Exact sample size determination for a single Poisson random sample. Biometrical Journal.
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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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Lisa V. Hampson, Björn Bornkamp, Björn Holzhauer, Joseph Kahn, Markus R. Lange, Wen‐Lin Luo, Giovanni Della Cioppa, Kelvin Stott & Steffen Ballerstedt. (2021) Improving the assessment of the probability of success in late stage drug development. Pharmaceutical Statistics 21:2, pages 439-459.
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Jane R. Temple & Jon R. Robertson. (2021) Conditional assurance: the answer to the questions that should be asked within drug development. Pharmaceutical Statistics 20:6, pages 1102-1111.
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Andrea Callegaro, Toufik Zahaf & Fabian Tibaldi. (2021) Assurance in vaccine efficacy clinical trial design based on immunological responses. Biometrical Journal 63:7, pages 1434-1443.
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William J. Ganley, Jagdeep Shur & Robert Price. (2020) Simulation Informed Design and Performance of In Vitro Bioequivalence Trials for Particle Size Distributions. The AAPS Journal 22:6.
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Anja Bertsche, Frank Fleischer, Jan Beyersmann & Gerhard Nehmiz. (2017) Bayesian Phase II optimization for time-to-event data based on historical information. Statistical Methods in Medical Research 28:4, pages 1272-1289.
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Fang Liu. (2018) Assessment of Bayesian expected power via Bayesian bootstrap. Statistics in Medicine 37:24, pages 3471-3485.
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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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ML Zierhut, P Bycott, MA Gibbs, BP Smith & P Vicini. (2016) Ignorance is not bliss: Statistical power is not probability of trial success. Clinical Pharmacology & Therapeutics 99:4, pages 356-359.
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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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