Biomarker evaluation and translation in the NHS-an NIHR applied programme in renal and liver disease

MP Messenger1&2, D Thompson1&2, C Sturgeon3, TC Wind1&2, RE Banks1 ,PJ Selby1&2, and co-investigators

University of Leeds, UK1; Leeds Teaching Hospitals NHS Trust, UK2; Royal Infirmary of Edinburgh, UK3

Website: www.biomarkerpipeline.org

IntroductionBiomarkers readily identifiable in body fluids using modern proteomic technologies could

potentially provide simple, accessible, and cost-effective tests for improved diagnosis, prognosis,

treatment selection and disease monitoring. However, mechanisms for identifying the most

promising biomarkers and taking them from the research laboratory into routine use in the NHS

are still poorly defined. To address this, the National Institute for Health Research (NIHR) has

funded a unique prototype programme with the aim of developing a rigorous evidence-based

approach to protein biomarker evaluation.

While focusing on aspects of liver and renal disease, the strategy established should be readily

transferable and is presented here. There are many opportunities within the structure for

associated translational projects. These could, for example, involve applying similar infrastructure

in other diseases, or could form integrated studies within the same renal and liver disease

infrastructure, for example investigating the impact of pre-analytical factors. We would be

delighted to discuss ideas for any such projects with interested parties.

Clinical Areas Chronic Liver Disease•5th most common cause of death in

the UK

•Biomarkers for early diagnosis of

cirrhosis

•1040 cross-sectional patientsRenal Cell Carcinoma•200,000 new cases every year

worldwide

•Biomarkers of prognosis and

monitoring

•1200 cross-sectional patients &

500 longitudinal patients

Renal Transplant•2000 renal transplants performed in

the UK every year

•Biomarkers for early diagnosis and

monitoring of graft function

•400 cross-sectional & 300

longitudinal patients

Programme StructureInvolving a multi-disciplinary team of health economists, statisticians, scientists and clinicians, as

well as collaboration with colleagues from the diagnostics industry, the integrated programme of

research is made up of three main workstreams.

delighted to discuss ideas for any such projects with interested parties.

Collaboration Structure

Programme Funded By: