Challenges and opportunities for conducting a vaccine trial during the COVID-19 pandemic in the United Kingdom. (October 2021)

• Record Type: Journal Article
• Authors: Török, M Estée; Underwood, Benjamin R; Toshner, Mark; Waddington, Claire; Sidhom, Emad; Sharrocks, Katherine; Bousfield, Rachel; Summers, Charlotte; Saunders, Caroline; McIntyre, Zoe; Morris, Helen; Piper, Jo; Calderon, Gloria; Dennis, Sarah; Assari, Tracy; de Rotrou, Anita Marguerie; Shaw, Ashley; Bradley, John; O'Brien, John; Rintoul, Robert C; Smith, Ian; Bullmore, Ed; Chatterjee, Krishna
• Other Names: Ribeiro Carla non-byline-author.; Pickup Lorinda non-byline-author.; de Jesus Ranalie non-byline-author.; Brookes Karen non-byline-author.; Vargas Phoebe non-byline-author.; McMahon Caroline non-byline-author.; Macor Chiara non-byline-author.; Pasquale Ciro non-byline-author.; Bermperi Areti non-byline-author.; Kourampa Evgenia non-byline-author.; Fabiculcana Marivic non-byline-author.; Zerudo Julie Ann non-byline-author.; Mendoza Vivien non-byline-author.; Fuller Stewart non-byline-author.; Glemas Claire non-byline-author.; Baker Sharon non-byline-author.; Lyons Greta non-byline-author.; Bishop Marina non-byline-author.; Coleman Siobhan non-byline-author.; Thomas Naomi non-byline-author.; Mlilo Vince non-byline-author.; Stanton Edward non-byline-author.; Michel Rachel non-byline-author.; Philips Julie non-byline-author.; Rice Heidi non-byline-author.; Garner Lucie non-byline-author.; Rosa Francesca non-byline-author.; Victor Saji non-byline-author.; Zamikula Julie non-byline-author.; Mepham Sue non-byline-author.; Hajee Fatima non-byline-author.; Quijano-Campos Juan Carlos non-byline-author.; Watson Laura non-byline-author.; Georgiou Christopher non-byline-author.; Worsley Jieniean non-byline-author.; Shamtally-Amode Djamilla non-byline-author.; Rahimi Ferishta non-byline-author.; Jones Heather non-byline-author.; Cruz Isabel non-byline-author.; Lindsay Gayle non-byline-author.; Sparke Christian non-byline-author.; Chapman Anna non-byline-author.; Keating-Fedders Katie non-byline-author.; Fahey Codie non-byline-author.; Johnson Danielle non-byline-author.; Worboys Lucy non-byline-author.; Hargreaves Simone non-byline-author.; Bucke Ashlea non-byline-author.; Carr Lindsay non-byline-author.; Hampshire Jackie non-byline-author.; Richardson Tracy non-byline-author.; Sharpe Jenny non-byline-author.; Whitehead Lynne non-byline-author.; Vyse Naval non-byline-author.; Kelleher Stephen non-byline-author.; Sherwood Mary-Beth non-byline-author.; Hughes Vicki non-byline-author.; Giraud Kim non-byline-author.;
• Is Part Of: Clinical trials. Volume 18:Number 5(2021)
• Page Start: 615
• Page End: 621
• Publication Date: 2021-10
• Subjects: COVID-19 -- SARS-CoV-2 -- coronavirus -- vaccine -- clinical trial -- pandemic; 615.5072405
• DOI: 10.1177/17407745211024764
• Languages: English
• ISSNs: 1740-7745

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.