tetano
Editor, Senior Moderator
Clin Trials
. 2021 Jun 22;17407745211024764.
doi: 10.1177/17407745211024764. Online ahead of print.
Challenges and opportunities for conducting a vaccine trial during the COVID-19 pandemic in the United Kingdom
M Estée Török[SUP] 1 2 3 [/SUP], Benjamin R Underwood[SUP] 4 5 [/SUP], Mark Toshner[SUP] 1 6 [/SUP], Claire Waddington[SUP] 1 2 [/SUP], Emad Sidhom[SUP] 4 5 [/SUP], Katherine Sharrocks[SUP] 2 3 [/SUP], Rachel Bousfield[SUP] 2 3 [/SUP], Charlotte Summers[SUP] 1 7 [/SUP], Caroline Saunders[SUP] 8 [/SUP], Zoe McIntyre[SUP] 9 [/SUP], Helen Morris[SUP] 8 [/SUP], Jo Piper[SUP] 8 [/SUP], Gloria Calderon[SUP] 4 [/SUP], Sarah Dennis[SUP] 6 [/SUP], Tracy Assari[SUP] 10 [/SUP], Anita Marguerie de Rotrou[SUP] 9 [/SUP], Ashley Shaw[SUP] 11 [/SUP], John Bradley[SUP] 1 10 12 [/SUP], John O'Brien[SUP] 5 [/SUP], Robert C Rintoul[SUP] 6 13 [/SUP], Ian Smith[SUP] 6 [/SUP], Ed Bullmore[SUP] 5 [/SUP], Krishna Chatterjee[SUP] 8 14 [/SUP], Cambridge COVID Vaccine Trial Team
Collaborators, Affiliations
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.
Keywords: COVID-19; SARS-CoV-2; clinical trial; coronavirus; pandemic; vaccine.
. 2021 Jun 22;17407745211024764.
doi: 10.1177/17407745211024764. Online ahead of print.
Challenges and opportunities for conducting a vaccine trial during the COVID-19 pandemic in the United Kingdom
M Estée Török[SUP] 1 2 3 [/SUP], Benjamin R Underwood[SUP] 4 5 [/SUP], Mark Toshner[SUP] 1 6 [/SUP], Claire Waddington[SUP] 1 2 [/SUP], Emad Sidhom[SUP] 4 5 [/SUP], Katherine Sharrocks[SUP] 2 3 [/SUP], Rachel Bousfield[SUP] 2 3 [/SUP], Charlotte Summers[SUP] 1 7 [/SUP], Caroline Saunders[SUP] 8 [/SUP], Zoe McIntyre[SUP] 9 [/SUP], Helen Morris[SUP] 8 [/SUP], Jo Piper[SUP] 8 [/SUP], Gloria Calderon[SUP] 4 [/SUP], Sarah Dennis[SUP] 6 [/SUP], Tracy Assari[SUP] 10 [/SUP], Anita Marguerie de Rotrou[SUP] 9 [/SUP], Ashley Shaw[SUP] 11 [/SUP], John Bradley[SUP] 1 10 12 [/SUP], John O'Brien[SUP] 5 [/SUP], Robert C Rintoul[SUP] 6 13 [/SUP], Ian Smith[SUP] 6 [/SUP], Ed Bullmore[SUP] 5 [/SUP], Krishna Chatterjee[SUP] 8 14 [/SUP], Cambridge COVID Vaccine Trial Team
Collaborators, Affiliations
- PMID: 34154428
- DOI: 10.1177/17407745211024764
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.
Keywords: COVID-19; SARS-CoV-2; clinical trial; coronavirus; pandemic; vaccine.