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Efficient adaptive designs for clinical trials of interventions for COVID-19
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Stallard, Nigel, Hampson, Lisa, Benda, Norbert, Brannath, Werner, Burnett, Thomas, Friede, Tim, Kimani, Peter K., Koenig, Franz, Krisam, Johannes, Mozgunov, Pavel, Posch, Martin, Wason, James, Wassmer, Gernot, Whitehead, John, Williamson, S. Faye, Zohar, Sarah and Jaki, Thomas (2020) Efficient adaptive designs for clinical trials of interventions for COVID-19. Statistics in Biopharmaceutical Research, 12 (4). pp. 483-497. doi:10.1080/19466315.2020.1790415
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WRAP-Efficient-adaptive-designs-clinical-trials-interventions-COVID-19-Stallard-2020.pdf - Accepted Version - Requires a PDF viewer. Download (1400Kb) | Preview |
Official URL: http://dx.doi.org/10.1080/19466315.2020.1790415
Abstract
The COVID-19 pandemic has led to an unprecedented response in terms of clinical research activity. An important part of this research has been focused on randomized controlled clinical trials to evaluate potential therapies for COVID-19. The results from this research need to be obtained as rapidly as possible. This presents a number of challenges associated with considerable uncertainty over the natural history of the disease and the number and characteristics of patients affected, and the emergence of new potential therapies. These challenges make adaptive designs for clinical trials a particularly attractive option. Such designs allow a trial to be modified on the basis of interim analysis data or stopped as soon as sufficiently strong evidence has been observed to answer the research question, without compromising the trial’s scientific validity or integrity. In this paper we describe some of the adaptive design approaches that are available and discuss particular issues and challenges associated with their use in the pandemic setting. Our discussion is illustrated by details of four ongoing COVID-19 trials that have used adaptive designs.
| Item Type: | Journal Article | ||||||||||||||||||
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| Subjects: | R Medicine > R Medicine (General) R Medicine > RA Public aspects of medicine |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | COVID-19 (Disease), Clinical trials, Adaptive sampling (Statistics), Clinical trials -- Statistical methods -- Research, Epidemics -- Research | ||||||||||||||||||
| Journal or Publication Title: | Statistics in Biopharmaceutical Research | ||||||||||||||||||
| Publisher: | Routledge | ||||||||||||||||||
| ISSN: | 1946-6315 | ||||||||||||||||||
| Official Date: | 2 July 2020 | ||||||||||||||||||
| Dates: |
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| Volume: | 12 | ||||||||||||||||||
| Number: | 4 | ||||||||||||||||||
| Page Range: | pp. 483-497 | ||||||||||||||||||
| DOI: | 10.1080/19466315.2020.1790415 | ||||||||||||||||||
| Status: | Peer Reviewed | ||||||||||||||||||
| Publication Status: | Published | ||||||||||||||||||
| Reuse Statement (publisher, data, author rights): | “This is an Accepted Manuscript of an article published by Taylor & Francis in Statistics in Biopharmaceutical Research on 02/07/2020, available online: http://www.tandfonline.com/10.1080/19466315.2020.1790415 | ||||||||||||||||||
| Access rights to Published version: | Restricted or Subscription Access | ||||||||||||||||||
| RIOXX Funder/Project Grant: |
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