Antimicrobials and Drug Resistance

Biomarkers in clinical research

Biomarkers are physical, functional or biochemical indicators of physiological or disease processes.( There are various types of biomarkers .) These key indicators can provide vital information in determining disease prognosis, in predicting of response to therapies, adverse events and drug interactions, and in establishing baseline risk. The incorporation of biomarker studies into early drug trials is complex. Thus the decision to proceed with studies of biomarkers should be based on balancing the strength of science, assay robustness, feasibility, and resources with the burden of proper sample collection on the patient and potential impact of the results on drug development.