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Wales to play major role in national trial for COVID-19 vaccine

Bwrdd Iechyd Addysgu Powys Powys Teaching Health Board Iechyd Cyhoeddus Cymru Public Health Wales Bwrdd Iechyd Prifysgol Aneurin Bevan University Health Board

Ymddiriedolaeth GIG Felindre Velindre NHS Trust Ymddiriedolaeth GIG Gwasanaethau Ambiwlans Cymru Welsh Ambulance Services NHS Trust Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board Wales to play major role in national trial for COVID-19 vaccine

Wales will play a vital role in finding a way out of the coronavirus pandemic as part of the next phase of a UK-led study. Cardiff University’s Centre for Trials Research is part of a collaboration coordinated by Health and Care Research Wales and involving Public Health Wales and Aneurin Bevan University Health Board, that will take part in the next phase of the vaccine trial sponsored by the University of Oxford and funded by CEPI (Coalition for Epidemic Preparedness Innovations) UK Research and Innovation.

Public Health Wales will lead the recruitment of 500 participants within Aneurin Bevan University Health Board for the Oxford Vaccine Group COVID-19 vaccine trial. The aim is to find a safe vaccine that will develop immunity against the virus and thus prevent the disease. The study aims to recruit 10,000 participants overall.

COVID-19 vaccine development is a vital part of the long-term response to the coronavirus pandemic and Wales will be joined by multiple other sites across the UK as part of phase 2/3 of the study. This phase of the trial is not open to members of the public. Volunteers will be staff aged 18 and over working within health and care settings within the Aneurin Bevan University Health Board area. This will include hospitals, GP practices, pharmacy, physiotherapy, community care and other non-clinical professions within secondary care who are deemed at risk of exposure to coronavirus. Eligible participants will receive details from the health board about how to participate if they wish. Dr Chris Williams, Principal Investigator for Public Health Wales and lead for the vaccine trial in Wales, said: “This is an important study to test the effectiveness of one of the main candidate vaccines for COVID-19 in Wales. If successful, vaccination will provide a route out of this pandemic. We will be recruiting participants for screening and administration of vaccine, and monitoring outcomes and safety.”

Bwrdd Iechyd Addysgu Powys Professor Sue Bale, Director of Research Powys Teaching Health Board and Development at Aneurin Bevan University Health Board, said: “Finding a vaccine for COVID-19 is thought to be the only way in which we can start to return Ymddiriedolaeth GIG Felindre Velindre NHS Trust to any degree of normality as a society. Scientists at Oxford University have developed a vaccine and the Health Board has the exciting opportunity for 500 of our staff to take part in this fantastic trial.” Professor Kieran Walshe, Director of Health and Care Research Wales, which is nationally co-ordinating research and study-set up in Wales, said: “Research is absolutely vital to finding new ways to deal with COVID-19 and its impact on health and care, and a vaccine is the ultimate goal. I am proud that researchers in Wales are working with national partners to find the most effective treatments, and to trial the Oxford vaccine here in Wales. Our research community and our health and social care staff, are making a real difference to finding a lasting solution to the COVID-19 pandemic.”

“We are delighted to be able to build on our previous collaborations with Public Health Wales and Aneurin Bevan University Health Board to help them to set up this vitally important vaccine trial. Usually a study like this would take months to set up, but with such a dedicated, skilled team working across organisational boundaries has achieved an amazing feat. This is a mighty step for research, even if it is only what may seem a small step in our national response to COVID-19.” Professor Kerry Hood

Director Centre for Trials Research Cardiff University

www.cardiff.ac.uk/centre-for-trials-research

SAIL Databank: Health data research during a global pandemic

What is SAIL Databank?

Based at Swansea University Medical School, SAIL Databank brings together anonymised person-level data from a variety of health and other public services/organisations, providing this as a resource via a secure portal known as a Trusted Research Environment or TRE.

A Welsh success story, SAIL Databank is the culmination of a decade of world leading innovation by a small team of data scientists, information governance experts and IT professionals at Swansea University, part-funded by Health and Care Research Wales. Their mission was to create a secure privacy-protecting platform which provides the widest possible access to linked data, without compromising data and privacy protection.

SAIL Databank has since established itself as one of the best-characterised population databanks anywhere in the world. Among its wealth of data sources, it contains 100 per cent secondary care and 80 per cent primary care coverage for the Welsh population, delivered through a partnership with the NHS Wales Informatics Service (NWIS).

Why is SAIL Databank important to COVID-19 research? SAIL Databank can monitor the impact of a very wide range of exposures and outcomes on the entire population using robustly de-identified data. It is possible to track the development of health conditions in individuals and nested within households and multi-occupancy residences such as care homes, as well as in organised settings such as schools. It is also possible to monitor the development and spread of diseases, and evaluate the impact of exposures and the effects of treatments on outcomes.

For COVID-19 research to be effective, approvals need to be considered promptly. The SAIL Databank team is able to make data available in as quickly as 48 hours whilst maintaining its defining set of governance protocols. This is during a period when the team are seeing as many data access requests from researchers in one week as they would more commonly see in a typical month.

Owing to these attributes, SAIL Databank is now used as the data repository for the ZOE COVID-19 Symptom Study app (in partnership with BREATHE – the Health Data Research Hub for Respiratory Health), and is a key partner in the COVIDENCE UK study, enabling numerous COVID-related studies to take place.

How is SAIL Databank contributing to COVID-19 research? Driven by an existing collaboration with Health Data Research (HDR) UK, a consortium set up to unite the UK’s health data to make it available for research, extensive health data research networks have been leveraged to facilitate each home nation’s TRE to provide data access for a high volume of COVID-19 research studies. SAIL Databank’s role is helping to inform and provide intelligence to the Welsh Government’s Tactical Advisory Group in its COVID response, subsequently feeding into the UK’s SAGE (Scientific Advisory Group for Emergencies).

In a weekly update to SAGE, at the beginning of June 2020, HDR UK recognised SAIL Databank as “leading the way across all dimensions, highlighting the benefits of having mature infrastructure in place from the outset.”

Of the COVID-19 research being undertaking across the four nations’ TREs, SAIL Databank is currently supporting two thirds of all active projects. The SAIL Databank team has successfully converted nearly half of the 118 data access requests into live projects. All specifically targeted towards COVID-19 research.

Research is now taking place under them following themes:

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Government and NHS emergency response planning

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Assessments of the impact of the pandemic on mental health

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Clinical trials comparing treatment pathways

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Investigations into the link between ethnicity and the severity of COVID-19

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Linking data to COVID-19 testing programmes

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Impacts on society’s most vulnerable groups

“Wales is a small connected country and our ability to link data anonymously means we shall get even greater value out of that… The advantage of our SAIL Databank is the ability to link up different records and what that means for the spread of coronavirus but also the rate at which people are recovering… The need for such a resource has never been greater.” Vaughan Gething AM

Cabinet Secretary for Health and Social Services

www.saildatabank.com

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