Annual Report 24/25 - Research at Cardiff and Vale UHB

Cardiff and Vale University Health Board is proud to be the largest NHS research organisation in Wales. Every year, we support hundreds of studies across almost all clinical areas—over 700 active studies and around 170 new approvals annually. These range from early-phase trials of cutting-edge therapies to observational studies that help improve everyday care. 

Research is vital to shaping modern healthcare. Clinical trials test new treatments and evaluate existing ones, ensuring that patients receive care that is safe, effective, and evidence-based. 

Research Activity  

Since 2021, the Health Board, in common with other large academic health trusts, has created a Joint Research Office (JRO) with Cardiff University to share expertise around research governance, costing and contracting processes and identify opportunities for collaborative working. 

Research Approvals  

Research will undergo a combination of national and local approvals before it is able to commence within the Health board.  The UK Policy Framework for Health and Social Care Research set out the principals of good practice in the management and conduct of health and social care research.  These principles protect and promote the interests of patients, service users and the public in health and social care research. Nationally, all research is required to be reviewed and approval issued by a Research Ethics Committee (REC) and the Health Research authority (HRA). The REC will conduct an independent review to ensure that the research proposal is ethical, considering the requirement and impact on the participant. The HRA assesses the governance and legal compliance of a study.  If the research is a clinical trial of a medicinal product (CTIMP) or a study of an unlicensed device the study requires review and authorization from the Medicines and Healthcare Product Regulatory Agency (MHRA). Additional national approvals are required if a study involved Genetic Modified Organisms, ionizing radiation or to obtain information without consent. 

Locally, the studies undergo a review of Capacity and Capability, conducted by the R&D department to ensure that the organization has appropriately trained staff resources and adequate facilities to ensure that the study protocol can be delivered. To make this assessment the R&D office engages with the researchers, departments and support services to ensure it is feasible to deliver and then obtain sign off by the directorate research lead, and directorate manager before final sign off by the JRO director. It is only once these reviews are completed that the study can commence within the health board.  

Around 25%-30% of studies in our portfolio are commercially funded. We have seen an increase in our non-commercial portfolio, this is in part to an increase in the number of CU studies opening within health board, from approximately 10% of our activity to 16%. This increase has been supported by the joint processes developed within the JRO supporting collaborations across organisations.  

Prompted by the Lord O’Shaughnessy review ‘Commercial clinical trials in the UK’ there has been a shift in emphasis at both NIHR and HCRW towards address the falling number of patients enrolled in commercial trials. Investment via the Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) scheme will see an additional £21m be invested into research infrastructure in Wales between 2025-2028 some of which will be allocated to Cardiff and Vale to boost commercial activity. Cardiff and Vale has been successful in a number of bids for this funding total value yet to be confirmed but we anticipate we will see an increase in commercial activity as a result.  

Recruitment to trials  

We recruited 4846 participants into non-commercial and commercial research studies in 2024-25. 

*total number of studies includes studies in follow up continuing to see patients. 

Health and Care Research Wales set a performance metric that 80% of all studies should recruit to time and target, meaning there is a requirement to recruit the agreed number of patients within the agreed study time frame.  

This is an important metric as it demonstrates our ability to deliver research and therefore will be seen as a favoured site for sponsors.  Currently we are performing at 65% for non-commercial and 63% for commercial studies. We are working with teams to ensure that the targets we set are realistic and deliverable. We also hold quarterly activity performance meetings with clinical management to identify issues and barriers to find resolution.  

Research Funding  

The department receive a budget of £6,389,389 from Health and Care Research Wales to support 175.32 WTE. An additional 32.4 WTE are funded by research infrastructure funding or reinvestment of commercial funds.   

Successfully awarded the following grants:

Health board Research Governance, Leadership and Accountability  

The UHB Joint Research Governance Group (JRGG) has been formed as part of the joint governance structures with the University to support the Joint Research Office (JRO). The aim of the group is to ensure robust Research Governance arrangements are in place for research which falls under the remit of the Joint Research Office (JRO) and the UK Policy Framework for Health and Social Care Research. 

JRGG is chaired by Professor Colin Dayan JRO Director and is attended by JRO Senior Management team, the R&D leads from each directorate, research delivery managers. There is also representation from Pharmacy, Biobank, Genetically modified Safety Committee (GMSC) and Information Governance (IG).  

The Cardiff Joint Research Office (JRO) reports into to the QSE (via the Medical Director).  

Since the September 2022 the JRGG has focused on  

• Inspection readiness  

• Oversight of Incidents and Breaches  

• Revised Audit Processes and scope of Audit cycle  

• Development of a joint risk register  

The risk register has been jointly developed with the team at Cardiff University and is broken down into; 

• MHRA regulatory requirements  
• Study Specific level risk which takes in to account the phase and complexity of the study, the experience of the lead clinician and team supporting them and how this compares to standard patient pathways.  

Currently 11 studies deemed to be high risk, mainly as they are phase 1 or phase 2 studies and included advanced therapies. The high-risk studies are required to report into JRGG quarterly via Clinical board leads to give an update on activity and performance.  

The JRGG committee has reviewed and approved an annual audit plan with a renewed focus on audits of research processes. The audits have been conducted using the AMAT system and are now mandatory across all research delivery teams.  

The first audit looked at the consenting process showing a high level of compliance for documentation of the consent process by an appropriate member of the team using the correct study specific documentations. Areas of learning identified documenting the time of the consent in the medical record and documenting that the patient received a copy for their records.  

Leading Research  

This year Cardiff and Vale researchers have continued to achieve success in securing large National Institute of Health Research (NIHR) Grants, the 4th in as many years. Dr Rachel Abbott in collaboration with Cardiff University Centre for Trials Research was awarded a £1.2 million NIHR Health Technology Assessment Grant to conduct the The EXCISE Study -Examining antibiotics for ulcerated skIn cancer surgery Excision: a pragmatic, multi-arm ‘durations’ design randomized controlled trial. The study with will open across multiple UK sites in 2025.   

Our researchers have also demonstrated the ability to create their own investment opportunities. The QuicDNA project led by Sian Morgan and Magda Meissner is looking to evaluate the use of liquid biopsies as a quicker less invasive option within the Lung cancer diagnostic pathways to gain quicker access to treatment for patients. The project started as a feasibility project funded by Health and Care Research Wales (HCRW) and through engagement and investment from various collaborators within industry partners, government, charities and patient groups raised funds to expand to a national study open at all health boards in Wales. It is hoped this work will form the foundation in which to explore possibilities for liquid biopsies to be used as a diagnostic tool in other tumour groups.  

There have been 9 investigator led research projects developed and set up this year by Cardiff and Vale staff.  It is hoped the success of our own investigators will continue to grow with the support of the Joint Research Office and collaboration with our academic partners.  

NHS R&D Framework 

Health and Care Research Wales (HCRW) has published a new R&D Framework in a drive to embed and integrate research into all aspects of health and care services in Wales. The framework outlines what ‘research excellence looks like’ within NHS organisations in Wales where research is embraced, integrated into services and is a core part of the organisations culture, broken down into 10 key pillars. A copy of the framework has been included in appendix 1.  

The R&D senior management team have re-established the Research Management Board to develop and deliver on the strategic plan for research. Workstreams are to be agreed but it is anticipated that the following will be an area of focus;  

• Embedding in standard care  

• Increasing commercial opportunities 

• Development of advanced therapies portfolio  

• Recognising Research Impact  

Patient Impact  

The Research Delivery Team whilst being an expert workforce consistently delivering high-quality participant care and prioritizing participant safety; the service provided has not been evaluated from the participants perspective nor had formal feedback been sought.  To address this the team developed a research participant feedback questionnaire and conducted a 3 month pilot.   

The results were overwhelmingly positive, indicating that participants would be willing to engage in future studies, felt the study visits were well organized and understood participation was voluntary with the option to withdraw at any time. 

“Everyone has been absolutely amazing. Caring, considerate and empathetic. Always available for support and have helped me beyond my expectations. Thank you!” 

However, feedback also provided insight to areas for improvement such as need for better directions/ signage to the CRF facility and lack of information about future research opportunities.  

Action has been taken to address the findings of the survey including additional signage and additional support from the communications team to make research activity more visible to our patients and service users.  The survey will be repeated annually to ensure that we are hearing and acting on the views of our patients.