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Challenges and opportunities for conducting a vaccine trial during the COVID-19 pandemic in the United Kingdom

Published version
Peer-reviewed

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Type

Article

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Authors

Underwood, Benjamin R 
Toshner, Mark 
Waddington, Claire 
Sidhom, Emad 

Abstract

The COVID-19 pandemic has resulted in unprecedented challenges for healthcare systems worldwide. It has also stimulated research in a wide range of areas including rapid diagnostics, novel therapeutics, use of technology to track patients and vaccine development. Here, we describe our experience of rapidly setting up and delivering a novel COVID-19 vaccine trial, using clinical and research staff and facilities in three National Health Service Trusts in Cambridgeshire, United Kingdom. We encountered and overcame a number of challenges including differences in organisational structures, research facilities available, staff experience and skills, information technology and communications infrastructure, and research training and assessment procedures. We overcame these by setting up a project team that included key members from all three organisations that met at least daily by teleconference. This group together worked to identify the best practices and procedures and to harmonise and cascade these to the wider trial team. This enabled us to set up the trial within 25 days and to recruit and vaccinate the participants within a further 23 days. The lessons learned from our experiences could be used to inform the conduct of clinical trials during a future infectious disease pandemic or public health emergency.

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Keywords

Design, COVID-19, SARS-CoV-2, coronavirus, vaccine, clinical trial, pandemic

Journal Title

Clinical Trials

Conference Name

Journal ISSN

1740-7745
1740-7753

Volume Title

18

Publisher

SAGE Publications

Rights

Embargo: ends 2021-06-22
Sponsorship
Health Foundation (Clinician Scientist Fellowship award to MET)
Academy of Medical Sciences (Clinician Scientist Fellowship award to MET)
Medical Research Council (Grant funding to CS)
National Institute for Health Research (NIHR Cambridge Biomedical Research Centre support)
National Institute for Health Research (NIHR Senior Investigator Emeritus to KC)
National Institute for Health Research (NIHR Senior Investigator award to EB)
Wellcome Trust (WT Investigator award to KC)
Cancer Research UK (Grant funding to RCR)