A year on from the launch of our Excellent Care Everywhere strategy, which sets out our ambitions to improve hospital care for the communities we serve at University Hospitals Sussex NHS Foundation Trust (UHSussex), we are also celebrating the first anniversary of the NIHR Commercial Research Delivery Centre (CRDC): Sussex.
The NIHR CRDC: Sussex is already helping to bring innovative treatments to people, with patients at UHSussex among the first in the UK to take part in an industry-sponsored clinical trial investigating a potential new treatment for people living with both heart failure and obesity.
The three-year Phase 3b study* at St Richard’s Hospital in Chichester is comparing a novel investigational treatment with a placebo to determine whether it can improve outcomes for people affected by these two increasingly common conditions. Heart failure affects around one million people across the UK and is one of the leading causes of hospital admission among older adults. Obesity is a major risk factor for developing heart failure and can also make the condition more difficult to manage. Research such as this has the potential to improve care for future patients living with both conditions.
Thanks to collaborative working through NIHR CRDC: Sussex, St Richard’s Hospital became the first UK site to open the study just 18 days after site selection. The first participant was consented only 35 days after site selection, and the team went on to randomise the first two participants in the UK.
The rapid achievement reflected months of careful preparation by the research team. Working closely with the industry sponsor, Consultant Cardiologist at St Richard’s Hospital, and Principal Investigator, Dr Wong, and Research Administrator, Marian Nelmes, along with the research nurse coordinator and a research facilitator, coordinated every stage of study set-up, ensuring the site was ready to recruit as soon as approvals were in place.
As a preferred site for the study, the team proactively identified eligible participants from their cardiology database before recruitment opened. The first three potential participants had been preidentified, enabling the first potential participants to be approached almost immediately once the study opened.
The first participants have spoken positively about their experience, saying they value the opportunity to contribute to research that could benefit future patients while also receiving regular follow-up appointments and specialist support from the cardiology research team.
Professor Martin Llewelyn, Director of Research and Innovation at University Hospitals Sussex NHS Foundation Trust, said: “At UHSussex, through our strategy Excellent Care Everywhere, we are committed to delivering excellent care for our communities today and for the future. Research gives patients access to tomorrow’s treatments today. By working closely with industry partners and delivering studies efficiently, we can offer more opportunities for people across Sussex to take part in research while contributing to discoveries that have the potential to improve care for patients everywhere.”
The study forms part of a growing portfolio of industry sponsored research delivered through the NIHR CRDC Sussex. Hosted by UHSussex in partnership with Sussex Partnership NHS Foundation Trust, NIHR CRDC Sussex provides a single coordinated entry point for industry sponsors wishing to conduct research across acute, mental health, community and primary care settings.
By streamlining study set-up and strengthening research infrastructure, the NIHR CRDC Sussex, a part of the CRDC UK Network is helping more people across Sussex gain faster access to innovative medicines, medical devices and healthcare technologies through commercial clinical research.
Recruitment to the study continues, with the UHSussex team already ahead of target after becoming the first site in the UK to randomise two participants into the trial.
*Phases of clinical trials
Phase 1 – Is it safe?
A small number of people receive the new treatment so researchers can understand how safe it is, identify any side effects and determine the best dose.
Phase 2 – Does it work?
The treatment is given to a larger group of people with the condition to see how well it works while continuing to monitor its safety.
Phase 3 – How does it compare?
The treatment is tested in much larger groups of people and compared with the current standard treatment or a placebo (a treatment with no active medicine). These studies help confirm how well the treatment works and how safe it is before it can be approved for wider use.
Phase 4 – What happens in everyday use?
Once a treatment has been approved and is being used in routine healthcare, researchers continue to monitor its long-term safety, effectiveness and any rare side effects.
Not every treatment goes through every phase in exactly the same way, and some studies combine phases or focus on gathering additional information after earlier trials have shown promising results.