The rapidly developing COVID-19 global pandemic has stimulated an enormous effort to develop vaccines against the coronavirus SARS-CoV-2. In a bid to support the international fight against COVID-19 and prevent overwhelming the NHS, local Clinical Research Networks (CRNs) were asked to swiftly set-up and deliver UK Urgent Public Health (UPH) COVID-19 clinical trials.
Research infrastructure across the UK and in collaboration with higher education institutions (HEIs) is currently funded by the National Institute for Health Research (NIHR) and research studies are sponsored by the pharmaceutical industry. Consequently, research teams have promptly responded to the Government's urgent call to provide best available evidence and find a way out of this pandemic through robust clinical trials (University Hospital Southampton, 2020). This is certainly true of my own research team at University Hospital Southampton (UHS) NHS Foundation Trust.
Our local CRN within the Wessex region is one of 15 local CRNs delivering health and social care research across England (NIHR, 2020a). UHS has been a research-active NHS Trust for several years and, as such, has been able to redeploy large numbers of research staff to support the local clinical service demands (NIHR, 2020b), as well as the set-up and delivery of the new and rapidly evolving range of vaccine trials.
UHS and Wessex CRN have played a key role in supporting the country to deliver an extensive COVID-19 portfolio of clinical trials and has been publicly praised for implementing these at pace. The high number of volunteers who came forward to enrol in such early phase research in Southampton were thanked for their altruism by Professor Chris Whitty, the UK's Chief Medical Officer (UHS, 2020).
UHS and CRN Wessex began recruiting their first healthy volunteers to the phase 1 Oxford Vaccine Trial at the end of April 2020. Support for a space large enough to enable safe delivery of the trial's activity schedule, while maintaining social distancing measures, was a challenge. Our excellent relationship and links with the University of Southampton ensured this was possible and space was found in the university's sports hall. Masses of equipment and resources were ordered and delivered ready for trial participants.
The UHS and the local NIHR Clinical Research Facility (CRF) research team has a small internal research education team who have facilitated the rapid upskilling of new and existing staff to carry out trial-based activities, including core clinical skills, for example vital signs, urinalysis, venesection, vaccination technique and informed consent, all en masse.
UHS and CRN Wessex staff have established the Hampshire Research Hub and support the Dorset Research Hub, and work across both sites in delivering a range of vaccine trials: Oxford AstraZeneca, Imperial College London COVAC, Novavax and Janssen phase 3; commencing in the New Year will be the new AstraZeneca monoclonal antibody passive immunisation and the Valneva phase 1 trials. It is vital for the education team to have close working relationships with the local lead research doctors, nurses and managers to enable a fluid response to trial and staff requirements. UHS education leads have also been crucial in supporting our team to upskill.
By embracing a dynamic approach to staff training, we can be equipped for whatever the future holds in delivering prompt, efficient and safe vaccine trials.
Southampton now has access to the Medicines for Healthcare products Regulatory Agency (MHRA)-approved Pfizer vaccine and we are vaccinating staff and patients as quickly and safely as possible. Delivering a successful vaccines programme to prevent the virus costing many more lives through our newly forged local, regional and national collaborative partnerships is now a reality.