The Leeds Institute of Clinical Trials Research, at the University of Leeds has one of the largest clinical trials portfolios in Europe, with over 100 ongoing trials and associated methodological projects, 8 infrastructure grants, an annual income of circa £5.5 million and an associated staff of 130, including a team of circa 25 specialist statisticians/trialists.
The Institute includes the Clinical Trials Research Unit (CTRU) which has played a leading role in national clinical research initiatives for example set up and leadership of the NIHR Trial Managers Network and the UKCRC Registered Clinical Trials Unit Network. The Institute has underpinned national clinical trials capacity development through support and development of new Chief Investigators, mentoring of developing CTUs and contributions to numerous national funding committees, trial steering and data monitoring committees. It is recognised nationally for its performance and quality and is currently the only Clinical Trials Unit in England receiving the top level pump priming funding award from NETSCC.
In the wounds research field the research portfolio encompasses pressure ulcer prevention, diabetic foot ulcers and leg ulcers. Work incudes three large multi-centre mattress trials, epidemiological research (prevalence and incidence), systematic reviews of pressure ulcer risk factors and quality of life, outcome measurement, instrument development, infection and prognostic factors for healing. More recently the pressure ulcer research has been underpinned by strong service user involvement through the Pressure Ulcer Service User Network and the use of innovative engagement methods.
The success of the wounds group has been effective clinical leadership, collaborative working and the Institutes methodological expertise and infrastructure. Within the HTC the role of the Institute is 4-fold:
• Service user involvement in research design and implementation
• Early phase trial design
• Statistical modelling of surrogate endpoints
• Phase 2 to 3 Go/No Decision Guidelines
• Large NIHR funded Phase 3 trials portfolio