Information For Professionals
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.
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