1. Challenges and opportunities for conducting a vaccine trial during the COVID-19 pandemic in the United Kingdom
- Author
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M Estée Török, Benjamin R Underwood, Mark Toshner, Claire Waddington, Emad Sidhom, Katherine Sharrocks, Rachel Bousfield, Charlotte Summers, Caroline Saunders, Zoe McIntyre, Helen Morris, Jo Piper, Gloria Calderon, Sarah Dennis, Tracy Assari, Anita Marguerie de Rotrou, Ashley Shaw, John Bradley, John O’Brien, Robert C Rintoul, Ian Smith, Ed Bullmore, Krishna Chatterjee, Carla Ribeiro, Lorinda Pickup, Ranalie de Jesus, Karen Brookes, Phoebe Vargas, Caroline McMahon, Chiara Macor, Ciro Pasquale, Areti Bermperi, Evgenia Kourampa, Marivic Fabiculcana, Julie Ann Zerudo, Vivien Mendoza, Stewart Fuller, Claire Glemas, Sharon Baker, Greta Lyons, Marina Bishop, Siobhan Coleman, Naomi Thomas, Vince Mlilo, Edward Stanton, Rachel Michel, Julie Philips, Heidi Rice, Lucie Garner, Francesca Rosa, Saji Victor, Julie Zamikula, Sue Mepham, Fatima Hajee, Juan Carlos Quijano-Campos, Laura Watson, Christopher Georgiou, Jieniean Worsley, Djamilla Shamtally-Amode, Ferishta Rahimi, Heather Jones, Isabel Cruz, Gayle Lindsay, Christian Sparke, Anna Chapman, Katie Keating-Fedders, Codie Fahey, Danielle Johnson, Lucy Worboys, Simone Hargreaves, Ashlea Bucke, Lindsay Carr, Jackie Hampshire, Tracy Richardson, Jenny Sharpe, Lynne Whitehead, Naval Vyse, Stephen Kelleher, Mary-Beth Sherwood, Vicki Hughes, Kim Giraud, Török, M Estée [0000-0001-9098-8590], and Apollo - University of Cambridge Repository
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medicine.medical_specialty ,COVID-19 Vaccines ,Design ,Best practice ,coronavirus ,01 natural sciences ,State Medicine ,010104 statistics & probability ,03 medical and health sciences ,0302 clinical medicine ,vaccine ,Political science ,Pandemic ,medicine ,Humans ,030212 general & internal medicine ,0101 mathematics ,Pandemics ,Pharmacology ,Clinical Trials as Topic ,Medical education ,SARS-CoV-2 ,business.industry ,pandemic ,Public health ,Teleconference ,Vaccine trial ,COVID-19 ,Information technology ,clinical trial ,General Medicine ,Project team ,United Kingdom ,3. Good health ,Clinical trial ,business - 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.
- Published
- 2021
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