NIHR Leeds CRF

Vision Our vision is to be a world class NIHR CRF, delivering safely and efficiently, internationally impactful experimental medicine trials across a wide range of clinically important conditions that are inclusive of our diverse population, spanning age groups and that improve outcomes for patients whilst reducing health inequalities in our population and beyond.

Background Through previous NIHR funding and Leeds Teaching Hospitals Trust (LTHT)/University of Leeds (UoL) capital investment (£5.5M since 2016), we now have strong foundations for an integrated, inclusive and ambitious enlarged NIHR Leeds CRF (LCRF) serving patients and researchers across our region.

This represents a major expansion of facilities and staff, to deliver high-quality research over multiple clinical sites in a single Trust.

These comprise our original NIHR Leeds CRF sites at St James s Hospital (re-located/enlarged) and Leeds General Infirmary, plus three additional CRF sites at Leeds Children s Hospital, the Dental Translational Clinical Unit and Chapel Allerton Hospital. Aims Increase the volume of high quality experimental medicine/translational research trials.

Enhance engagement and inclusion of patients from underserved groups. Attract, retain and develop a diverse group of the best multidisciplinary researchers. Expand partnerships with public funders/charities and the life sciences industry. Develop our leadership contributions to the CRF Network and wider NIHR.

Strategy The newly enlarged NIHR LCRF represents a step-change, transforming Leeds early phase/experimental medicine research in established strengths (solid tumour/haemato-oncology and cardiovascular) and others new to our NIHR portfolio (e.g. musculoskeletal disease, surgery, pathology, oral/dental health, antimicrobial resistance and paediatrics).

We will expand from a focus on drugs (including oncolytic viruses) to cell-based therapies, medical devices and digital.

Studies will be prioritised that map onto our new aims and research/disease strengths, in particular early phase trials of innovative new therapeutics, which address major unmet needs and incorporate strong Patient and Public Involvement, Engagement and Participation (PPIEP).

With an experienced leadership/delivery team and robust governance, successful trial delivery will be ensured by monitoring/responding to (i) study-set up time, (ii) first patient recruitment in <30 days of local approval, and (iii) recruitment to time/target, whilst monitoring participants diversity using the NIHR INCLUDE Framework.

We will work collaboratively with NHS/academic/NIHR infrastructures while strengthening engagement with local and national charities.

Our trial pipeline will be further strengthened by proactive engagement with businesses/industry through a new Business Development and Innovation Team. Workforce development will be enhanced by managing staff as an integrated cross-site team.

Training will be delivered by the LTHT Research Academy to improve patient care, safety and trial delivery while over time continuing to build capacity, expertise and sustainability.

Our PPIEP work will build on learning from the COVID-19 pandemic with a renewed focus on equality, diversity and inclusion of underserved groups/individuals, addressing health inequalities with a commitment to engage and increase participation in our trials.

Summary The enlarged NIHR LCRF represents a unique opportunity to expand, streamline and accelerate delivery of high quality trials.

This will ensure increased access for patients across the region to clinical trials, ultimately improving health and well-being, and reducing existing health inequalities.