Biological Markers and Clinical Development

Biological markers (biomarkers) are objectively measured characteristics or analytes evaluated as an indicator of normal and pathogenic processes as well as pharmacologic responses to therapeutic intervention.64,65 Biomarkers can be used to diagnose, monitor disease, or predict a response (Figure 3). It is the predictive value of a biomarker that has great potential to accelerate and improve both drug discovery and development and ultimately increase patient benefit. As rather low success rates in translating preclinical to clinical activity and druggable target hit rates have resulted in a number of drugs being withdrawn from clinical trials/market,66 the need for predictive biomarkers is apparent.

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