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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

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Official URL: http://dx.doi.org/10.1080/19466315.2020.1799857

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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
Subjects: Q Science > QH Natural history
Q Science > QR Microbiology
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), Biodiversity, Pathogenic microorganisms, Clinical trials
Journal or Publication Title: Statistics in Biopharmaceutical Research
Publisher: Routledge
ISSN: 1946-6315
Official Date: 22 July 2020
Dates:
DateEvent
22 July 2020Published
18 July 2020Accepted
Volume: 12
Number: 4
Page Range: pp. 461-477
DOI: 10.1080/19466315.2020.1799857
Status: Peer Reviewed
Publication Status: Published
Publisher Statement: 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
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
HBC.2017.0219Agentschap Innoveren en Ondernemenhttp://dx.doi.org/10.13039/100012331

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