Challenges and opportunities for conducting a vaccine trial during the COVID-19 pandemic in the United Kingdom.
Clin Trials
; 18(5): 615-621, 2021 10.
Article
in English
| MEDLINE | ID: covidwho-1280563
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
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Clinical Trials as Topic
/
Pandemics
/
COVID-19 Vaccines
/
COVID-19
Type of study:
Observational study
/
Prognostic study
/
Qualitative research
/
Randomized controlled trials
Topics:
Vaccines
Limits:
Humans
Country/Region as subject:
Europa
Language:
English
Journal:
Clin Trials
Journal subject:
Medicine
/
Therapeutics
Year:
2021
Document Type:
Article
Affiliation country:
17407745211024764
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