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Clinical trials impacted by the COVID-19 pandemic : adaptive designs to the rescue?
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Kunz, Cornelia Ursula, Jörgens, Silke, Bretz, Frank, Stallard, Nigel, Van Lancker, Kelly, Xi, Dong, Zohar, Sarah, Gerlinger, Christoph and Friede, Tim (2020) Clinical trials impacted by the COVID-19 pandemic : adaptive designs to the rescue? Statistics in Biopharmaceutical Research, 12 (4). pp. 461-477. doi:10.1080/19466315.2020.1799857 ISSN 1946-6315.
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WRAP-clinical-trials-impacted-COVID-19-pandemic-adaptive-designs-rescue-Stallard-2020.pdf - Accepted Version - Requires a PDF viewer. Download (1123Kb) | Preview |
Official URL: http://dx.doi.org/10.1080/19466315.2020.1799857
Abstract
Very recently the new pathogen severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified and the coronavirus disease 2019 (COVID-19) declared a pandemic by the World Health Organization. The pandemic has a number of consequences for ongoing clinical trials in non-COVID-19 conditions. Motivated by four current clinical trials in a variety of disease areas we illustrate the challenges faced by the pandemic and sketch out possible solutions including adaptive designs. Guidance is provided on (i) where blinded adaptations can help; (ii) how to achieve type I error rate control, if required; (iii) how to deal with potential treatment effect heterogeneity; (iv) how to utilize early read-outs; and (v) how to utilize Bayesian techniques. In more detail approaches to resizing a trial affected by the pandemic are developed including considerations to stop a trial early, the use of group-sequential designs or sample size adjustment. All methods considered are implemented in a freely available R shiny app. Furthermore, regulatory and operational issues including the role of data monitoring committees are discussed.
| Item Type: | Journal Article | ||||||
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| Subjects: | Q Science > QH Natural history Q Science > QR Microbiology 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), Biodiversity, Pathogenic microorganisms, Clinical trials | ||||||
| Journal or Publication Title: | Statistics in Biopharmaceutical Research | ||||||
| Publisher: | Routledge | ||||||
| ISSN: | 1946-6315 | ||||||
| Official Date: | 22 July 2020 | ||||||
| Dates: |
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| Volume: | 12 | ||||||
| Number: | 4 | ||||||
| Page Range: | pp. 461-477 | ||||||
| DOI: | 10.1080/19466315.2020.1799857 | ||||||
| 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 22 Jul 2020, available online: http://www.tandfonline.com/10.1080/19466315.2020.1799857 | ||||||
| Access rights to Published version: | Restricted or Subscription Access | ||||||
| Date of first compliant deposit: | 5 August 2020 | ||||||
| Date of first compliant Open Access: | 22 July 2021 | ||||||
| RIOXX Funder/Project Grant: |
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