The study formally commenced in April 2022 and was designed to evaluate investigational booster vaccines that could protect against the COVID-19 Omicron variant and other variants

Around 3,000 people were expected to take part in the trial at several dozen hospitals across the UK, with Aberdeen Royal Infirmary selected as the only Scottish base.

The investigational Omicron variant vaccines being studied were compared to a booster dose of Moderna’s COVID-19 vaccine, SPIKEVAX, which had received conditional marketing authorisation in the EU.

All participants at Aberdeen Royal Infirmary received either an investigational Omicron variant vaccine or SPIKEVAX.

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Due to different strains of COVID-19 circulating, there was an urgent need to develop vaccination plans that provided greater protection

A booster vaccine that protected against COVID-19 variants, including the Omicron variant, was considered to be a crucial public health tool to help curb the pandemic.

The mRNA-1273-P305 clinical trial evaluated the safety and immune response of the investigational booster vaccines mRNA-1273.529 and mRNA-1273.214, two specially formulated versions of the COVID vaccine designed to target the Omicron variant specifically.

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In April 2022, participants attended for a screening visit at the Aberdeen Royal Infirmary site, before being vaccinated

They were then asked to return to the trial site four or five times in total across month one, month three, month six and month 12, as well as taking part in up to four phone calls with the clinical trial doctor to monitor for any symptoms.

Participants were further requested to use an eDiary app on their smartphone or a provided smartphone to report any COVID-19 symptoms.

Participants were closely monitored by the clinical trial team if any symptoms of COVID-19 were reported at any time throughout their participation.

Volunteers had to meet several criteria. All participants needed:

• To be 16 years or older
• To have received a second dose of Moderna, Pfizer, AstraZeneca or Janssen vaccine, OR had a third dose of either Moderna or Pfizer at least three months ago
• To not have tested positive for COVID since November 8, 2021
• Not had ‘significant’ exposure to someone with COVID in the previous two weeks (within two metres of them for 15 minutes or more)

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The Grampian study’s first participant was recruited on 12 April and the last on 15 April

While an ambitious target of 100 was set, the total number of participants recruited over the four days was 72. This was higher than most UK sites and among the fastest recruiting sites.

The site was commended for the quality and completeness of the data and research processes by the trial sponsor’s appointed clinical research organisation.

This trial helped bring the new vaccine into standard clinical practice by rapidly generating evidence on key outcomes and strengthening collaborative relationships.

Having experience to hand in running vaccines studies enabled NHS Grampian to find, recruit, and complete screening visits at an average of 18 subjects per day.

The ability to rapidly set up, undertake and successfully complete vaccine studies is key to building resilience against global pandemics of infectious diseases, as recently demonstrated with COVID-19 where a cross-stakeholder response to urgent, unmet need was vital to preventing its spread.

HCV Research UK is a consortium of leading UK clinicians and researchers, backed by the Medical Research Foundation

It was set up to address critical gaps in understanding of hepatitis C virus particularly in relation to:

• The clinical course of HCV-related disease
• The optimal clinical management of the virus including the effectiveness and long-term impact of antiviral therapies
• The viral and host genetic factors influencing prognosis

The consortium brings together an infrastructure connecting 60 major UK adult and paediatric liver centres involved in the management of HCV-infected patients throughout Scotland, England and Wales.

In Scotland:

• HCV Research UK officially launched in 2013 at University of Glasgow
• 25% of the cohort recruited at sites across Scotland
• Infrastructure supported by existing knowledge and expertise at national agencies (Public Health England and Health Protection Scotland) and the Medical Research Council–University of Glasgow Centre for Virus Research

“This project provides the research community with access to data and samples to tackle the problems we face with HCV infection in the UK. We are at an exciting time with new therapies that can cure infection more quickly than previous treatments and with fewer side-effects. HCV Research UK is playing a pivotal role in building a national picture of their effectiveness. This information is essential for healthcare providers and the NHS so that use of the drugs can be optimised for curing infection and the liver disease that is caused by HCV.”
Professor John McLauchlan, Associate Director of the MRC-University of Glasgow Centre for Virus Research and co-chair HCV Research UK

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Chronic hepatitis C virus (HCV) is a global problem affecting in excess of 71 million individuals and causing half a million deaths every year from liver disease

In Scotland, approximately 37,000 individuals are chronically infected with Hepatitis C. HCV Research UK has created a bespoke clinical research database linked to a biorepository of samples and treatment information:

• A national cohort in excess of 10,000 HCV-infected patients, supported by an integrated, standardised clinical database with demographic, clinical and laboratory parameters
• A biobank of biological samples from the cohort for studies of host and viral factors associated with disease outcome and treatment response
• Significant viral and host sequence data demonstrating the value and potential of the cohort and biobank
• A bioinformatics database from the viral and host sequence data, which can be linked to the clinical database
• Epidemiological data and biological samples are available to all researchers in both academia and the biopharmaceutical industry upon successful application to the HCV Research UK TDAC
• HCV Research UK now contains bespoke cohorts for particular groups of patients, for example those receiving new therapies and monitoring those who have been successfully treated for the development of disease for up to 5 years

“While there has been considerable progress with understanding the biology of the hepatitis C virus and improvements in healthcare provision, many issues relevant to the characteristics of HCV infection in the UK remain unresolved. The patients taking part in this cohort study are providing clinical data and samples to provide researchers with vital information about the longer-term impact of the disease.”
Professor John Dillon, NHS Research Scotland Hepatology Lead and Professor of Hepatology and Gastroenterology, in the School of Medicine, Ninewells Hospital, University of Dundee

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AstraZeneca’s Integrated Genomics Initiative will leverage information from up to two million genomic sequences over 10 years

The goal is to identify rare genetic variations that are associated with disease and how different individuals respond to treatment.

The programme involves collaboration with world renowned partners including the Wellcome Trust Sanger Institute in the UK, Human Longevity Inc. in the USA and Finland’s Institute for Molecular Medicine.

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In Scotland, a range of collaborative initiatives bring together our single healthcare provider, the NHS, with academic researchers and industry partners

The aim of Precision Medicine Scotland is to position Scotland as a global centre of excellence in precision medicine. The centre is the strategic initiative that brings together and facilitates interactions between healthcare, life sciences and academic organisations to deliver precision medicine programmes effectively and efficiently.

“Working together with NHS Scotland, Scottish universities and Stratified Medicine Scotland will be a really important part of our strategy. This collaboration will provide access to consented genomic samples, electronic health records and importantly the ability to recall patients for deeper clinical investigation to help us better understand the underlying causes of disease”
Mene Pangalos, Executive Vice President IMED Biotech Unit and Global Business Development, AstraZeneca

Precision Medicine Scotland provides access for industry partners, like AstraZeneca, to a
host of high-quality data assets and associated services. It also provides direct access to a network of world class clinical and academic institutions working at the leading edge of precision medicine research and real world application.

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NHS Research Scotland works collaboratively across all Health Boards to provide a comprehensive and complete service. This national approach results in fast, efficient and reliable support to deliver high-quality clinical trials in Scotland

GlaxoSmithKline (GSK) HARMONY Study is a long-term, randomised, double-bind, placebo controlled study to determine the effect of albiglutide when added to standard blood glucose lowering therapies on major cardiovascular events in patients with Type 2 diabetes.

This involved a total population of 9400 randomised patients from 590 sites over 29 countries:

• 19 UK Sites initially, moving to 26
• Five NHS Research Scotland (NRS) sites (secondary care in Scotland)
• Three primary care Scottish sites
• 11 additional sites in the UK; eight secondary care, three primary care

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Overall, average study set-up time was fastest at NHS Research Scotland sites when compared to other sites in the UK

• Average contract negotiation time was 64 days shorter in NRS when compared with other sites in the UK and 17 days shorter than the UK average
• Average time to NHS permission from submission of full document set was 80 days shorter in NRS sites when compared with other secondary care sites in the UK and 30 days faster than the UK average
• Average time to site activation from full document set was 32 days shorter in NRS sites when compared with other secondary care sites in the UK and 14 days shorter compared to the UK average

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Significant recruitment achievements included first UK patient randomised and highest recruiting UK site

NRS sites had the shortest average time between site activation and both first subject first visit (FSFV) and First Subject Randomised:

• Recruitment to NRS sites has been rapid and steady
  • NRS achieved 83% recruitment compared to 71% nationally and 63% in other UK secondary care sites
  • 80% of sites in Scotland (4/5) have achieved 90% of their recruitment target
  • NRS have randomised more patients to the study than any other group of sites
  • NRS are 15th internationally in terms of percentage recruitment to target compared with 22nd for the UK overall

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NHS Research Scotland aims to streamline the start-up of studies with more than one site in Scotland

The NRS Generic Review process allocates an experienced reviewer as the initial single point for Sponsors/CROs to perform a study-level governance review and negotiate a single contract draft and budget for all sites in Scotland.

The single budget and contract draft process is based on the following assumptions:

• Use of the ABPI model Clinical Trial Agreement (mCTA)
• Use of the current version of the NIHR costing templates completed to reflect the requirements of protocol

While the generic review is ongoing, local site staff can work in parallel to prepare site for study initiation.

Communications and proactivity of the Sponsor during the review and negotiation process accelerates the start-up process.

NRS Generic Review process and commitment to a single NRS price and contract template resulted in rapid average contract negotiation timelines and fast overall start-up when compared to other sites in the UK

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A new treatment designed to improve survival in patients with liver failure by providing extracorporeal hepatic support continuously for up to five days

Vital Therapies, Inc. is a biotherapeutic company developing ELAD®, an extracorporeal human hepatic cell-based liver treatment.

“This is an important study. We believe that use of ELAD allows time for the patient’s native liver to recover from an acute decompensation, stabilize, and then potentially regenerate, or to maintain the patient until liver transplantation can occur.

"The connected, collaborative and streamlined approach in Scotland has enabled rapid start-up of this study at two centres of excellence within a four month period that included the Christmas holidays. The sites have proven pedigree in this type of trial having contributed to the UK-wide STOPAH trial. The Vital Therapies study ultimately hopes to translate ELAD into a possible new treatment option for liver failure patients who have a high mortality risk.”
Andrew Henry, VP Clinical Operations, Vital Therapies Inc

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An efficient and responsive infrastructure, enabled this complex study, with intensive resource requirement, to be set up within 4 months from initial contact

• NHS Research Scotland (NRS) feasibility service identified two sites in Glasgow and Dundee
• Rapid review of study completed via NRS Permissions Co-ordinating Centre and negotiation of national standard contract and budget
• Hepatology Clinical Lead provided national oversight, advice and co-ordinated approach to discussions

“Collaboration and early engagement are critical in complex trials such as VTL-308 and I’ve been delighted to bring this trial to Scotland offering opportunities for patients to access innovative new treatments in liver disease”
Professor John Dillon, NRS Hepatology Clinical Lead

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Headquartered in Texas, USA, MicroTransponder Inc has developed therapies to treat several neurological conditions

The device used in this study, the Vivistim® System, is surgically implanted just below the collar bone and delivers electrical stimulation to the vagus nerve. The stimulation, which is given in conjunction with rehabilitation physiotherapy, is believed to cause the brain to be more receptive to the recovery training exercises.

"Arm mobility is a major problem and is associated with poor quality of life in patients who have had a stroke. It is estimated to affect about 75% of all patients in the early months and remains a permanent issue for about half of patients so new treatments are urgently required.

"The group receiving active stimulation with the device showed a 9-point improvement in upper-limb Fugl-Meyer (UEFM) score. This magnitude of change would mean different things for different patients, depending on where they start on the scale. If they start at 20 — which is not much function at all — they might regain some grasp ability so they might be able to carry a plate, for example. If they were in the 30s to start with, they would probably already have the grasp function but they would be able to get back to do more specific tasks."
Prof Jesse Dawson (Lead Investigator), University of Glasgow; Consultant Stroke Physician, NHS Greater Glasgow and Clyde

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NHS Research Scotland (NRS) efficiently supports clinical research studies from all Life Sciences sector including pharmaceutical, biotechnology and medical technology companies

We simplify access to Scotland’s clinical research infrastructure, including world class facilities, expert investigators and well characterised groups of patients, enabling industry to benefit from:

• A single point of contact for industry
• Single contract draft and commercial price for Scotland
• Co-ordinated access to clinical investigators and patients
• Strong collaboration between NHS, academia and industry
• Streamlined and timely clinical trial approvals
• Sustained permissions performance among the best in Europe
• Efficient start up and managed delivery

“Despite this being a complex trial requiring surgical implantation of a medical device, the infrastructure, expertise and support available in Scotland enabled rapid start-up of this study and real-world testing of our device. Our Scottish site was our best recruiter and acted as a trusted partner in the development of our program. We look forward to working with the team on our phase three clinical trial.”
Frank McEachern, CEO, MicroTransponder Inc.

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