Case studies
A selection of studies highlighting the breadth of our portfolio and experience in trial delivery
Respiratory disorders
ASPECT
Chief Investigator: Nick Maskell
A pneumonia trial – the largest ever – will investigate whether aspirin can reduce the risk of a heart attack or stroke in patients who are admitted to hospital with pneumonia.May: ASPECT research study | News and features | University of Bristol
The research study ‘Aspirin after hospitalisation with Pneumonia to prevent cardiovascular Events randomised Controlled Trial’ is being managed by the Bristol Trials Centre.
This randomised controlled trial is recruiting 22,600 patients from over 60 hospitals across England. Findings from the four-year study will support future treatment guidelines, if appropriate, for patients with pneumonia. If aspirin is shown to be effective it could prevent up to 3,000 heart attacks and strokes a year in England alone.
Reproductive health
PARTNER
Chief Investigator: Christy Burden
A new tool which is able to identify early in pregnancy a woman’s chance of preterm birth or of developing problems with the placenta that may lead to stillbirth will be tested across 26 NHS Trusts for 36 months. The University of Bristol-led device trial, will test the Tommy’s App, a Clinical Decision Support Tool and will involve around 39,000 women each year. “December: tommys-app | News and features | University of Bristol
Public health and prevention
AFRI-C
Chief Investigator: Alastair Hay
A major randomised controlled trial that has investigated the effectiveness of air filtration systems in preventing respiratory infections (such as coughs, colds and flu) and COVID-19 among care home residents in England. The AFRI-c (Air Filters to Prevent Respiratory Infections including COVID-19 in Care Homes) study, which received funding from the National Institute for Health Research (NIHR), has been led by researchers at the University of Bristol and managed by the Bristol Trials centre. 2021: AFRI-c study announcement | Centre for Academic Primary Care | University of Bristol
Previously, I led all RCT elements myself, from the application to employing and line managing the staff to deliver the trials. I now work with the University’s Bristol Trial Centre from inception to publication and I would not go back. My experience is that the BTC provides high quality methodological and managerial support, freeing me to focus on writing the papers and designing the next studies.
Primary care
TIGER
Chief Investigator: Matthew Ridd
TIGER (Trial of food allergy IgE tests for Eczema Relief) is a National Institute for Health and Care Research (NIHR) funded randomised clinical trial recruiting 493 children with eczema, aged between three months and two years, from GP surgeries in and around West of England, Hampshire and Dorset, Oxfordshire and Greater Manchester. May: tiger-study | News and features | University of Bristol
Participants are randomised to two groups: one receiving standard care and the other receiving dietary advice, based on the results of skin prick tests to cow’s milk, hen’s egg, wheat and soya. At the end of the study, it will be clearer whether the test-guided dietary advice improves disease control in children with eczema.
Under it’s new director, Becky Kerney, the BTC has strengthened and streamlined its processes making it much more resilient to the challenges of delivering RCTs, while retaining its expertise around complex interventions and delivering trials in children and primary care.
Musculoskeletal disorders
HIPPY Trial
Chief Investigator: Elsa Marques
The HIPPY Trial brings together clinicians, researchers, and patients, working collaboratively to understand how the decisions around choosing implants for people undergoing hip replacement are made and find out which implants are best for those under 70 years of age.
Bristol Trials Centre is a fantastic unit to work with, their expertise and experience in delivering large and challenging trials makes the seemingly impossible achievable and efficient. Their interest and support for earlier translational research and building that to the point of testing in definitive trials has also been hugely beneficial for me as a researcher.
We owe some of the most innovative design aspects of our trial to the BTC advisers who helped us secure funding for our very large and ambitious trial. BTC uses a team science approach and works collaboratively with our team of already established researchers. The trial management is proactive, energetic, and helpful in sorting all sorts of issues in this particularly tricky trial. Looking forward to continuing working with BTC in this great collaboration!
Infection
ComFluCOV vaccine trial (completed)
Chief Investigator: Rajeka Lazarus
The Bristol Trial Centre was one of the recipients of the COVID-19 Collaboration in Research award at the CRN West of England research awards 2022 for their work on the ComFluCOV trial, which was delivered in just 6 months during the early part of the pandemic. October 2022, Bristol Trials Centre
The ComFluCOV vaccine study was a collaboration between the University of Bristol, University Hospitals Bristol and Weston NHS Foundation Trust and the University of Oxford, and run by the Bristol Trials Centre. The study looked at the safety, as well as the immune responses, when giving currently approved COVID-19 vaccines at the same time as the recommended influenza (flu) vaccines from the 2020/21 flu season programme.
The initial study results were published in The Lancet in November 2021, and used to inform UK immunisation policy
Cancer
MARS-2
Chief Investigator: Mr Eric Lim
The aim of the MARS2 study was to compare surgery – (extended) pleurectomy decortication – with no surgery with respect to overall survival, cost-effectiveness and quality of life at regular intervals for patients with malignant pleural mesothelioma.
MARS 2 was a phase 3, national, multicentre, open-label, parallel two-group, pragmatic, superiority randomised controlled trial conducted in the UK. The trial took place across 26 hospitals.
The trial found:
Extended pleurectomy decortication was associated with worse survival to 2 years, and more serious adverse events for individuals with resectable pleural mesothelioma, compared with chemotherapy alone.’ Extended pleurectomy decortication and chemotherapy versus chemotherapy alone for pleural mesothelioma (MARS 2): a phase 3 randomised controlled trial The Lancet Respiratory Medicine
Anaesthesia, perioperative medicine, and pain
LOLIPOP
UK Chief Investigator: Mark Edwards
The LOLIPOP trial is a large, international CTIMP for breast cancer patients undergoing surgery. It aims to investigate whether chronic pain can be prevented by giving a local anaesthetic, lidocaine, intravenously during and up to 24 hours after breast cancer surgery.
Bristol Trials Centre is the Coordinating Centre for the UK arm of this pragmatic, international, multi-centre, randomised placebo-controlled, safety and superiority trial.