Hull Health Trials Unit awarded provisional registration to the UKCRC Registered Clinical Trials Network

The Hull Health Trials Unit (HHTU) at Hull York Medical School, University of Hull has been awarded provisional registration to the UKCRC Clinical Trials Network – the UK Clinical Research Collaboration’s national network of clinical trials units in the UK.

Judith Cohen, Director of the HHTU, is delighted. She says, ‘The UKCRC Registration Process was established with the aim of improving thequality of conduct of clinical trials research in the UK through a rigorous accreditation process for CTUs. Members of the network have been assessed by an international panel of experts in clinical trials research so to have been recognised by such a prestigious network is testament to the skills and expertise within the unit’.

The Hull Health Trials Unit (HHTU) is an academic-led trials unit housed within the award winning Allam Medical Building – at the heart of the University of Hull’s £28 million health campus. A partnership between the University of Hull and Hull University Teaching Hospitals NHS Trust, HHTU was established in 2017 with the aim of providing dedicated support for the design and delivery of multi-centre clinical trials in this region.

Judith says,

it has long been an ambition of both partners to develop a clinical trials unit capable of delivering multi centre trials. Within HTTU we have not only the expertise but also the specialist IT and QA systems needed to design and deliver high quality clinical trials or healthcare studies – providing support for clinicians and academics to lead on research that will focus on real benefits to patients and, importantly, which will have measurable impact.

The Unit was established alongside the Methods Hub within the University’s Institute for Clinical and Applied Health Research, which houses applied health researchers with expertise in clinical trials, statistics, health services research (qualitative and quantitative methods), literature reviewing, clinical and population epidemiology, health economics, health psychology, implementation science, health sociology, public health, patient and public involvement.

The HHTU is already making a difference providing full clinical trials support for a number of trials in collaboration with researchers from the University of Hull, Hull York Medical School and Hull University Teaching Hospitals NHS Trust. These studies include:

• MABEL is a definitive trial, and as a drug trial comes under MHRA regulations. The aim of the trial us to ascertain the clinical effectiveness, safety and long term effects of Kapanol® 5mg and 10mg capsules (oral sustained-release morphine) for chronic breathlessness in the short term. (insert link to MABEL project)
• BREATHE is a feasibility study, which aims to assess whether it is possible to conduct a large scale randomised controlled trial (RCT) in a pre-hospital emergency care setting. The intervention is delivered by paramedics at the time of ambulance call-out. ( insert link to Breathe project)
• The Leukaemia in Pregnancy Study is establishing a national registry of cases of Leukaemia in Pregnancy, and will inform National Guidelines about the treatment of these women with the aim of improving outcomes for mothers and babies.

To gain UKCRC Registration, CTUs must demonstrate a track record of experience in coordinating multi-centre trials, expert staff to develop studies, robust quality assurance systems and evidence of long term viability of capacity for trials coordination. Now that the HHTU has achieved provisional registration the next step is to further grow the portfolio of multi-centre studies and demonstrate that we can support these from the design stage to publication of results. HHTU now have a registration number, which enables them to be added as the supporting CTU on NIHR and similar collaborative funding applications.

Professor Una Macleod, Dean of Hull York Medical School, says ‘at Hull York Medical School and the University of Hull we are focused on making a difference to the lives of patients through our teaching and research. Ensuring we have expertise and systems in place is critical to our success. I am delighted that the Hull health Trials Unit has received this recognition and look forward to hearing the outcome of current and future trials it is involved with.’

For further information about the Hull Health Trials Unit, including how to contact us to discuss your trial idea visit https://www.hyms.ac.uk/research/research-centres-and-groups/clinical-trials-and-methods