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Original Articles

Alternative Views On Setting Clinical Trial Futility Criteria

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Pages 976-993 | Received 03 Jul 2013, Accepted 04 Dec 2013, Published online: 11 Aug 2014

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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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Shogo Nomura. (2021) Sample Size Determination in Group-Sequential Trials Assessing Interim Futility by Intermediate Composite Endpoints. Statistics in Biopharmaceutical Research 13:4, pages 492-503.
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Ryuji Uozumi & Chikuma Hamada. (2020) Utility-Based Interim Decision Rule Planning in Adaptive Population Selection Designs With Survival Endpoints. Statistics in Biopharmaceutical Research 12:3, pages 360-368.
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Qiqi Deng & Xiaoqi Lu. (2018) Choosing Timing and Boundary for Futility Analysis Based on Cost-Effectiveness Assessment. Statistics in Biopharmaceutical Research 10:2, pages 104-111.
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Dong Xi, Paul Gallo & David Ohlssen. (2017) On the Optimal Timing of Futility Interim Analyses. Statistics in Biopharmaceutical Research 9:3, pages 293-301.
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Articles from other publishers (20)

Xiaofei Wang & Stephen L George. (2023) Futility monitoring for randomized clinical trials with non-proportional hazards: An optimal conditional power approach. Clinical Trials 20:6, pages 603-612.
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Hao Li, Dooti Roy & Qiqi Deng. (2023) Bayesian hierarchical modeling in interim futility analysis for two parallel clinical trials. Statistics in Medicine.
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Elias Laurin Meyer, Peter Mesenbrink, Nicholas A. Di Prospero, Juan M. Pericàs, Ekkehard Glimm, Vlad Ratziu, Elena Sena & Franz König. (2023) Designing an exploratory phase 2b platform trial in NASH with correlated, co-primary binary endpoints. PLOS ONE 18:3, pages e0281674.
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Paul Gallo & Satrajit Roychoudhury. (2023) Challenges in Implementing Futility Schemes, with Reference to Aducanumab. Therapeutic Innovation & Regulatory Science.
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Fulvio Di Stefano, Matthieu Pannaux, Anne Correges, Stephanie Galtier, Veronique Robert & Gaelle Saint‐Hilary. (2022) A comparison of estimation methods adjusting for selection bias in adaptive enrichment designs with time‐to‐event endpoints. Statistics in Medicine 41:10, pages 1767-1779.
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Elias Laurin Meyer, Peter Mesenbrink, Cornelia Dunger‐Baldauf, Ekkehard Glimm, Yuhan Li & Franz König. (2022) Decision rules for identifying combination therapies in open‐entry, randomized controlled platform trials. Pharmaceutical Statistics 21:3, pages 671-690.
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Dominic Magirr & José L Jiménez. (2022) Design and analysis of group-sequential clinical trials based on a modestly weighted log-rank test in anticipation of a delayed separation of survival curves: A practical guidance. Clinical Trials 19:2, pages 201-210.
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Oleksandr Sverdlov, Ekkehard Glimm & Peter Mesenbrink. 2022. Principles and Practice of Clinical Trials. Principles and Practice of Clinical Trials 1455 1485 .
Oleksandr Sverdlov, Ekkehard Glimm & Peter Mesenbrink. 2020. Principles and Practice of Clinical Trials. Principles and Practice of Clinical Trials 1 32 .
Munyaradzi Dimairo, Philip Pallmann, James Wason, Susan Todd, Thomas Jaki, Steven A. Julious, Adrian P. Mander, Christopher J. Weir, Franz Koenig, Marc K. Walton, Jon P. Nicholl, Elizabeth Coates, Katie Biggs, Toshimitsu Hamasaki, Michael A. Proschan, John A. Scott, Yuki Ando, Daniel Hind, Douglas G. Altman, Munyaradzi Dimairo, Toshimitsu Hamasaki, Susan Todd, Christopher J. Weir, Adrian P. Mander, James Wason, Franz Koenig, Steven A. Julious, Daniel Hind, Jon Nicholl, Douglas G. Altman, William J. Meurer, Christopher Cates, Matthew Sydes, Yannis Jemiai, Deborah Ashby, Christina Yap, Frank Waldron-Lynch, James Roger, Joan Marsh, Olivier Collignon, David J. Lawrence, Catey Bunce, Tom Parke, Gus Gazzard, Elizabeth Coates, Marc K. Walton, Sally Hopewell, Philip Pallmann, Thomas Jaki, Katie Biggs, Michael A. Proschan, John A. Scott & Yuki Ando. (2020) The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. Trials 21:1.
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Xieran Li, Carolin Herrmann & Geraldine Rauch. (2020) Optimality criteria for futility stopping boundaries for group sequential designs with a continuous endpoint. BMC Medical Research Methodology 20:1.
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Munyaradzi Dimairo, Philip Pallmann, James Wason, Susan Todd, Thomas Jaki, Steven A Julious, Adrian P Mander, Christopher J Weir, Franz Koenig, Marc K Walton, Jon P Nicholl, Elizabeth Coates, Katie Biggs, Toshimitsu Hamasaki, Michael A Proschan, John A Scott, Yuki Ando, Daniel Hind & Douglas G Altman. (2020) The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design. BMJ, pages m115.
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Qiqi Deng, Ying-Ying Zhang, Dooti Roy & Ming-Hui Chen. (2019) Superiority of combining two independent trials in interim futility analysis. Statistical Methods in Medical Research 29:2, pages 522-540.
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Kaspar Rufibach, Dominik Heinzmann & Annabelle Monnet. (2019) Integrating phase 2 into phase 3 based on an intermediate endpoint while accounting for a cure proportion—With an application to the design of a clinical trial in acute myeloid leukemia. Pharmaceutical Statistics 19:1, pages 44-58.
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Ryuji Uozumi, Shinjo Yada & Atsushi Kawaguchi. (2019) Patient recruitment strategies for adaptive enrichment designs with time-to-event endpoints. BMC Medical Research Methodology 19:1.
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Xiaoyin F Fan, Paul Gallo, Guoqin Su, Ronald Menton & Florencia Segal. (2018) A proof-of-concept-to-confirmatory multiple adaptation design in the development of an anti-viral treatment. Statistical Methods in Medical Research 28:12, pages 3491-3501.
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Tobias Mütze, Ekkehard Glimm, Heinz Schmidli & Tim Friede. (2018) Group sequential designs with robust semiparametric recurrent event models. Statistical Methods in Medical Research 28:8, pages 2385-2403.
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Tobias Mütze, Ekkehard Glimm, Heinz Schmidli & Tim Friede. (2018) Group sequential designs for negative binomial outcomes. Statistical Methods in Medical Research 28:8, pages 2326-2347.
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E. Lesaffre, M.J. Edelman, N.H. Hanna, K. Park, N. Thatcher, S. Willemsen, B. Gaschler-Markefski, R. Kaiser & C. Manegold. (2017) Statistical controversies in clinical research: futility analyses in oncology–lessons on potential pitfalls from a randomized controlled trial. Annals of Oncology 28:7, pages 1419-1426.
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Deli Wang, Lu Cui, Lanju Zhang & Bo Yang. 2016. New Developments in Statistical Modeling, Inference and Application. New Developments in Statistical Modeling, Inference and Application 121 147 .

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