Biomarkers can be used in clinical practice to identify risk for or
diagnose a disease, stratify patients, assess disease severity or
progression, predict prognosis, or guide treatment. Biomarkers have
major potential benefits for patients and the NHS, particularly in
contributing to "personalised" and/or "stratified" medicine and
improved safety. The need for new biomarkers in the context of
"personalised" medicine is well recognised.
Better biomarkers should lead to improvements in outcomes and more
efficient, cost-effective and evidence-based use of NHS resources. With
ongoing technological developments, particularly in proteomics, the
rate of identification of potential new biomarkers is increasing.
However there is no quick and reliable way to decide which of the
markers are good enough to be useful clinically. Various stages in the
.biomarker pipeline. have been defined but banks of high quality
samples and associated clinical data are key to such initiatives.
Encouragingly, the need for national strategies for the rapid
evaluation and introduction of new biomarker tests is now better
appreciated, for example by the
NIH in the
USA (www.nihroadmap.nih.gov/) and by the Royal College of Pathologists
in the UK. In drug development biomarkers may be used to help determine
how a drug works in the body, to determine a biologically effective
dose of a drug, to help assess whether a drug is safe or effective, and
to help identify patients most likely to respond to a treatment, or are
least likely to suffer an adverse event when treated with a drug.
Biomarkers can sometimes be used as part of the approval process for a
drug or treatment, to inform regulatory decision-making.
The NIHR biomarker pipeline programme is dedicated to working with
businesses to drive innovation across all areas of liver/kidney cancer
in particular and protein biomarkers in general.
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