Patient Population

LTHT serves one of the largest and most diverse patient populations in the UK, with 26.6% of the population identifying as non-White British, delivering care across Leeds and providing specialist services throughout West Yorkshire and more widely. Our catchment/referral population is approx.5 million. 

Clinical Research Infrastructure

Between April 2024 and March 2025, LTHT managed/ delivered a complex and diverse research portfolio, recruiting 22,275 participants to 1,413 active research studies with more than 50% of participants recruited into interventional studies. LTHT is one of the highest recruiters to commercially sponsored interventional trials in the UK.

This breadth and scale reflect the strength of LTHT’s Research & Innovation (R&I) infrastructure, across early-phase, late-phase, interventional, observational and advanced therapy studies in all major clinical specialties. R&I provides research governance and operational support including feasibility, contracting, sponsorship oversight, quality assurance and Good Clinical Practice (GCP) compliance working alongside speciality research teams embedded within clinical services integrating clinical trials with routine clinical care/pathways.

Clinical Trial Facilities

The National Institute for Health and Care Research (NIHR) Leeds Clinical Research Facility (CRF), in academic partnership with the University of Leeds, a leading Russell Group University, is one of the largest in the UK and offers purpose-built, designated clinical environments for early-phase and experimental medicine research, comprising 1,681 m² of consulting rooms, 36 single- and multi-bed/chair treatment areas, and multiple laboratory/sample-processing facilities. The 77-specialist research delivery workforce operates flexibly as “one CRF across five sites within a single Trust.” 

Dedicated infrastructure supporting cellular therapy and haematology research based at St. James’s University Hospital (SJUH), adjacent to the CRF includes JACIE (Joint Accreditation Committee of ISCT & EBMT) certified clinical areas for delivery of advanced cellular therapies including allogeneic/autologous stem cell transplants, chimeric antigen receptor- T (CAR-T) cells, gene therapy, and other novel Advanced Therapy Medicinal Products (ATMP) trials. Specialist staff are trained in ATMP handling, toxicity grading, and late effects monitoring in accordance with Good Manufacturing Practice (GMP). The CRF and Haematology Wards are supported by LTHT crash team services and co-located with intensive care. The Haematological Malignancy Diagnostic Service (HMDS) and Leeds Pathology Service, support molecular diagnostics, genomics, immunophenotyping, flow cytometry, and biomarker analysis, with access to world-leading translational research and digital pathology.

LTHT Research Academy develops research capacity providing training, mentoring and support for clinicians, researchers and other staff involved in clinical/ translational research.

Additional support services include advanced imaging facilities (e.g. CT, MRI, PET-CT, interventional radiology). The onsite aseptic pharmacy prepares and dispenses IMPs and houses a Biotherapy Suite for the preparation of ATMPs up to BSL2. Dedicated clinical trials dispensaries provide further support through specialist IMP handling, storage and dispensing.

ATMP Clinical Trial Specialism or Expertise

LTHT has nationally recognised ATMP clinical trial delivery capability with expertise across many specialties. We have successfully recruited to, and delivered, Advanced Therapy Investigational Medicinal Products (ATIMP) trials in haematology, oncology and cardiology with recent expansion into rheumatology, ophthalmology and dentistry/ oral health.

A weekly meeting with R&I reviews the ATMP portfolio and another meeting with PIs/ delivery teams oversees study set up and delivery, supporting rapid problem-solving that has markedly reduced trial initiation times. Cross-directorate collaboration allows specialties to co-deliver ATMP trials with the Haematology and CRF teams ensuring compliance with JACIE requirements.

Cell therapy studies are supported by NHS Blood and Transplant in Leeds, ensuring Human Tissue Authority (HTA) and JACIE compliance and adherence to national protocols that standardise apheresis and cell storage across UK sites. Apheresis is delivered on site at SJUH, with cell storage provided by NHS Blood Transfusion (NHSBT) (Barnsley). This nationally aligned service offers recognised expertise and integrates NHS care and clinical trials.

Specialist Technology On-Site

LTHT has a full range of specialist imaging, pathology and other support services located adjacent to the CRF and Haematology clinical services supported by a skilled multidisciplinary research workforce governance, finance, contracting, QA and education/training teams.

Licence or Accreditations

LTHT holds JACIE accreditation across haematology wards/ outpatients and maintains the required HTA licences for human application. It complies with NHSBT governance for apheresis, cell processing and storage, and meets all Medicines and Healthcare products Regulatory Agency (MHRA) and Good Clinical Practice (GCP) requirements for safe and compliant delivery of cell and gene therapy trials.

ATMP Trial Experience

LTHT has experience in the delivery of both commercial and academic ATMP trials across multiple specialties, including trials initiated and led by local Investigators.

Useful links

Research and Innovation Academy

Research – Leeds Teaching Hospitals NHS Trust

Home – NIHR Leeds Clinical Research Facility