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Original Articles

On the Independence of Data Monitoring Committee in Adaptive Design Clinical Trials

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Pages 853-867 | Received 01 Aug 2010, Accepted 10 Mar 2012, Published online: 31 May 2012

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Zohra Djeridi & Hayet Merabet. (2019) A hybrid Bayesian-frequentist predictive design for monitoring multi-stage clinical trials. Sequential Analysis 38:3, pages 301-317.
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Thomas Burnett, Pavel Mozgunov, Philip Pallmann, Sofia S. Villar, Graham M. Wheeler & Thomas Jaki. (2020) Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs. BMC Medicine 18:1.
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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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Michael Rosenblum, Peter Miller, Benjamin Reist, Elizabeth A. Stuart, Michael Thieme & Thomas A. Louis. (2018) Adaptive design in surveys and clinical trials: similarities, differences and opportunities for cross‐fertilization. Journal of the Royal Statistical Society: Series A (Statistics in Society) 182:3, pages 963-982.
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Philip Pallmann, Alun W. Bedding, Babak Choodari-Oskooei, Munyaradzi Dimairo, Laura Flight, Lisa V. Hampson, Jane Holmes, Adrian P. Mander, Lang’o Odondi, Matthew R. Sydes, Sofía S. Villar, James M. S. Wason, Christopher J. Weir, Graham M. Wheeler, Christina Yap & Thomas Jaki. (2018) Adaptive designs in clinical trials: why use them, and how to run and report them. BMC Medicine 16:1.
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Laura E Bothwell, Jerry Avorn, Nazleen F Khan & Aaron S Kesselheim. (2018) Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov. BMJ Open 8:2, pages e018320.
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Victoria Borg Debono, Lawrence Mbuagbaw & Lehana Thabane. (2017) Sharing interim trial results by the Data Safety Monitoring Board with those responsible for the trial’s conduct and progress: a narrative review. Trials 18:1.
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Thomas R Fleming, David L DeMets, Matthew T Roe, Janet Wittes, Karim A Calis, Amit N Vora, Alan Meisel, Raymond P Bain, Marvin A Konstam, Michael J Pencina, David J Gordon, Kenneth W Mahaffey, Charles H Hennekens, James D Neaton, Gail D Pearson, Tomas LG Andersson, Marc A Pfeffer & Susan S Ellenberg. (2017) Data monitoring committees: Promoting best practices to address emerging challenges. Clinical Trials 14:2, pages 115-123.
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Claire McKay Bowen, Fang Liu & James Wheeler. (2015) Are more of my patients developing side effects than expected?. Practical Radiation Oncology 5:3, pages e255-e261.
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Matilde Sanchez-Kam, Paul Gallo, John Loewy, Sandeep Menon, Zoran Antonijevic, Jared Christensen, Christy Chuang-Stein & Thomas Laage. (2014) A Practical Guide to Data Monitoring Committees in Adaptive Trials. Therapeutic Innovation & Regulatory Science 48:3, pages 316-326.
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Shein-Chung Chow. (2014) Adaptive Clinical Trial Design. Annual Review of Medicine 65:1, pages 405-415.
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Min Lin & Shein-Chung Chow. (2013) Data Monitoring Committees in adaptive clinical trials. Clinical Investigation 3:7, pages 605-607.
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Zoran Antonijevic, Paul Gallo, Christy Chuang-Stein, Vladimir Dragalin, John Loewy, Sandeep Menon, Eva R. Miller, Caroline Claire Morgan & Matilde Sanchez. (2013) Views on Emerging Issues Pertaining to Data Monitoring Committees for Adaptive Trials. Therapeutic Innovation & Regulatory Science 47:4, pages 495-502.
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Maya H. Buch, Sue Pavitt, Mahesh Parmar & Paul Emery. (2013) Creative trial design in RA: optimizing patient outcomes. Nature Reviews Rheumatology 9:3, pages 183-194.
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Christopher S Coffey, Bruce Levin, Christina Clark, Cate Timmerman, Janet Wittes, Peter Gilbert & Sara Harris. (2012) Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop. Clinical Trials 9:6, pages 671-680.
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