Research priorities in biomarkers and surrogate end-points.

British Journal of Clinical Pharmacology
Jeffrey K Aronson

Abstract

Ideal tests of the effects of therapeutic interventions measure the desired outcomes; however, the desired outcomes are not always easily measured or may be long-term objectives. Biomarkers and surrogate end-points are often cheaper and easier to measure and can be measured over a shorter time span. They can be used in screening, diagnosing, staging, and monitoring diseases, in monitoring responses to interventions, and in various aspects of drug discovery and development. They can be extrinsic to the body or intrinsic, and can relate to any point in the pharmacological chain, at the molecular, cellular, tissue, or organ level. Problems arise when the relation between the pathophysiology of the disease and the mechanism of action of the intervention is not properly understood; when adverse effects obviate therapeutic effects; when confounding factors, such as other drugs, alter the surrogate independently of the final end-point; when a biomarker persists after resolution of the disease; and when the concentration-effect curves for the effects of an intervention on the primary outcome and the surrogate are different. Use of biomarkers may also be hindered by poor reproducibility of measurement techniques. Challenges for clinical...Continue Reading

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Citations

Sep 28, 2012·Thrombosis and Haemostasis·Patrizia FerroniGiovanni Davì
Dec 18, 2012·British Journal of Clinical Pharmacology·Lionel D LewisJames M Ritter
Dec 13, 2016·JBI Database of Systematic Reviews and Implementation Reports·Catalin Tufanaru
Dec 28, 2017·European Journal of Clinical Investigation·Gerard Marshall Raj
Nov 23, 2017·AJR. American Journal of Roentgenology·Olena Weaver, Jessica W T Leung
Dec 7, 2013·Arthritis Research & Therapy·R Andrew Moore
Jul 22, 2015·Journal of Neuromuscular Diseases·Annemieke Aartsma-Rus, Pietro Spitali
Mar 18, 2017·Current Protocols in Pharmacology·Jeffrey K Aronson, Robin E Ferner
Apr 3, 2020·Diagnostics·Francyne KubaskiRoberto Giugliani

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