Challenges and opportunities for conducting a vaccine trial during the COVID-19 pandemic in the United Kingdom
Creators: name: Török, M Estée
name: Underwood, Benjamin R
name: Toshner, Mark
name: Waddington, Claire
name: Sidhom, Emad
name: Sharrocks, Katherine
name: Bousfield, Rachel
name: Summers, Charlotte
name: Saunders, Caroline
name: McIntyre, Zoe
name: Morris, Helen
name: Piper, Jo
name: Calderon, Gloria
name: Dennis, Sarah
name: Assari, Tracy
name: De Rotrou, Anita Marguerie
name: Shaw, Ashley
name: Bradley, John
name: O’Brien, John
name: Rintoul, Robert C
name: Smith, Ian
name: Bullmore, Ed
name: Chatterjee, Krishna
name: Ribeiro, Carla
name: Pickup, Lorinda
name: De Jesus, Ranalie
name: Brookes, Karen
name: Vargas, Phoebe
name: McMahon, Caroline
name: Macor, Chiara
name: Pasquale, Ciro
name: Bermperi, Areti
name: Kourampa, Evgenia
name: Fabiculcana, Marivic
name: Zerudo, Julie Ann
name: Mendoza, Vivien
name: Fuller, Stewart
name: Glemas, Claire
name: Baker, Sharon
name: Lyons, Greta
name: Bishop, Marina
name: Coleman, Siobhan
name: Thomas, Naomi
name: Mlilo, Vince
name: Stanton, Edward
name: Michel, Rachel
name: Philips, Julie
name: Rice, Heidi
name: Garner, Lucie
name: Rosa, Francesca
name: Victor, Saji
name: Zamikula, Julie
name: Mepham, Sue
name: Hajee, Fatima
name: Quijano-Campos, Juan Carlos
name: Watson, Laura
name: Georgiou, Christopher
name: Worsley, Jieniean
name: Shamtally-Amode, Djamilla
name: Rahimi, Ferishta
name: Jones, Heather
name: Cruz, Isabel
name: Lindsay, Gayle
name: Sparke, Christian
name: Chapman, Anna
name: Keating-Fedders, Katie
name: Fahey, Codie
name: Johnson, Danielle
name: Worboys, Lucy
name: Hargreaves, Simone
name: Bucke, Ashlea
name: Carr, Lindsay
name: Hampshire, Jackie
name: Richardson, Tracy
name: Sharpe, Jenny
name: Whitehead, Lynne
name: Vyse, Naval
name: Kelleher, Stephen
name: Sherwood, Mary-Beth
name: Hughes, Vicki
name: Giraud, Kim
Publisher: name: Apollo - University of Cambridge Repository
Year: 2021
Subjects: Design
COVID-19
SARS-CoV-2
coronavirus
vaccine
clinical trial
pandemic

description: 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.