Contributions of Valid Biomarkers to Clinical Research (Capabilities of Biomarkers)

• Delineation of events between exposure and disease
• Establishment of dose-response
• Identification of early events in natural history
• Identification of mechanisms by which exposure and disease are related
• Reduction in misclassification of exposures or risk factors and disease
• Establishment of variability and effect modification
• Enhanced individual and group risk assessments

Most biomarkers of exposure measure antecedent factors thought to modify (increase or decrease) the risk of developing the disease investigated. The advantage of a biomarker of exposure over a history of exposure is that it estimates the actual “internal” dose of the exposure.

Thus, the use of biomarkers improves the sensitivity and specificity of the measurement of the exposures or risk factors and therefore enables PREDICTABILITY in determining the likelihood of occurrence and severity of diseases.