. Author manuscript; available in PMC: 2012 Nov 18.

Published in final edited form as: J Proteomics. 2011 May 4;74(12):2632–2641. doi: 10.1016/j.jprot.2011.04.023

Table 1.

Components of validation for biomarkers in clinical trials for drug development.

Analytical validation (also known as verification)	Clinical validation	Clinical utility

Accuracy	Sensitivity: true positive designation	Evaluation of risk and benefit of diagnosis and consequent treatment resulting from the test
Precision	Sensitivity: true positive designation
Reproducibility	Specificity: true negative designation
Intrinsic measurements of error	Behavior of biomarker in a population as a function of biological variability
	Positive and negative predictive value