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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 . pp. 1-26. doi:10.1080/19466315.2020.1790415 (In Press)

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Official URL: http://dx.doi.org/10.1080/19466315.2020.1790415

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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
Subjects: R Medicine > R Medicine (General)
R Medicine > RA Public aspects of medicine
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology
Faculty of Medicine > Warwick Medical School
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:
DateEvent
2 July 2020Published
24 June 2020Accepted
Date of first compliant deposit: 7 July 2020
Page Range: pp. 1-26
DOI: 10.1080/19466315.2020.1790415
Status: Peer Reviewed
Publication Status: In Press
Publisher Statement: “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:
Project/Grant IDRIOXX Funder NameFunder ID
MC_UU_00002/6[MRC] Medical Research Councilhttp://dx.doi.org/10.13039/501100000265
MR/N028171/1)[MRC] Medical Research Councilhttp://dx.doi.org/10.13039/501100000265
MC_UU_00002/14[MRC] Medical Research Councilhttp://dx.doi.org/10.13039/501100000265
NIHR-SRF-2015-08-001[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
853966Innovative Medicines Initiative 2 Joint UndertakingUNSPECIFIED

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