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NIHR Liver/Renal Biomarker Programme Final Report: Evaluating the benefits for patients and the NHS of new and existing biological fluid biomarkers in liver and renal disease

Selby, Peter; Banks, Rosamonde; Gregory, Walter; Hewison, Jenny; Rosenberg, William; Altman, Douglas; Deeks, Jon J; McCabe, Christopher; Parkes, Julie; Sturgeon, Catherine; Thompson, Douglas; Twiddy, Maureen; Bestall, Janine; Bedlington, Joan; Hale, Tilly; Dinnes, Jac; Jones, Marc; Lewington, Andrew; Messenger, Michael P; Napp, Vicky; Sitch, Alice; Tanwar, Sundeep; Vasudev, Naveen S; Baxter, Paul; Bell, Sue; Calder, Nicola; Corrigan, Neil; Del Galdo, Francesco; Heudtlass, Peter; Hulme, Claire; Lippiatt, Carys; Livingstone, Tobias; Longo, Roberta; Potton, Matthew; Roberts, Stephanie; Trainor, Sebastian; Welberry Smith, Matthew; Neuberger, James; Thorburn, Douglas; Richardson, Paul; Christie, John; Sheerin, Neil; Gibbs, Paul; Edwards, Anusha; Soomro, Naeem; Adeyoju, Adebanji; Stewart, Grant; Hrouda, David; Cairns, David A.; Hutchinson, Michelle


Peter Selby

Rosamonde Banks

Walter Gregory

Jenny Hewison

William Rosenberg

Douglas Altman

Jon J Deeks

Christopher McCabe

Julie Parkes

Catherine Sturgeon

Douglas Thompson

Janine Bestall

Joan Bedlington

Tilly Hale

Jac Dinnes

Marc Jones

Andrew Lewington

Michael P Messenger

Vicky Napp

Alice Sitch

Sundeep Tanwar

Naveen S Vasudev

Paul Baxter

Sue Bell

Nicola Calder

Neil Corrigan

Francesco Del Galdo

Peter Heudtlass

Claire Hulme

Carys Lippiatt

Tobias Livingstone

Roberta Longo

Matthew Potton

Stephanie Roberts

Sebastian Trainor

Matthew Welberry Smith

James Neuberger

Douglas Thorburn

Paul Richardson

John Christie

Neil Sheerin

Paul Gibbs

Anusha Edwards

Naeem Soomro

Adebanji Adeyoju

Grant Stewart

David Hrouda

David A. Cairns

Michelle Hutchinson


Protein biomarkers are naturally occurring substances that can be measured, often in fluids such as blood or urine, and which provide information about a patient and their illness. Different diseases have different biomarkers. When people become ill, changes in biomarker levels may occur before any clinical symptoms or signs become apparent. Measuring biomarkers in blood or urine is simple, safe and may help the doctor diagnose which disease the patient has, determine how severe it is, help choose the best treatment and help detect if the disease is getting worse or better. Unfortunately, for many diseases there are not enough biomarkers that are of proven usefulness in patient care today. New developments in research mean that many more are now being discovered but there is no quick and reliable way to decide which of the markers are good enough to be useful clinically. While our research proposal focusses on diseases of the liver and kidney, in the future it can also serve as the "blueprint" for similar work in other diseases. It is aimed at developing a structure and methods to assess the clinical usefulness of biomarkers as quickly and efficiently as possible. The research is divided into three parallel workstreams : 1. Identification of the best research methods for monitoring disease or treatment with biomarkers - the lack of understanding this has hampered this field so far. 2. The creation of a sample "banking" system for collecting and storing patient samples and relevant clinical data from large numbers of patients. This will allow the immediate testing of potential new biomarkers now and in the future. The best biomarkers would then go on to full trials to see if patients and the NHS would benefit from their use. 3. A clinical trial at multiple hospitals in the UK of three new biomarkers for liver damage (together called the "Enhanced liver fibrosis" or "ELF", test). We will find out if ELF can give early warning of dangerous liver damage (cirrhosis) and therefore reduce the risk of major complications. This trial may radically alter the way in which patients with liver disease can be looked after clinically. This research programme will benefit patients and the NHS by ensuring that biomarkers in the future can be evaluated and introduced more rapidly, improving clinical management for each individual patient and leading to better use of NHS resources.


Selby, P., Banks, R., Gregory, W., Hewison, J., Rosenberg, W., Altman, D., …Hutchinson, M. (2017). NIHR Liver/Renal Biomarker Programme Final Report: Evaluating the benefits for patients and the NHS of new and existing biological fluid biomarkers in liver and renal disease. Southampton: NIHR

Report Type Research Report
Publication Date May 1, 2017
Deposit Date Dec 11, 2017
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