CNS trauma biomarkers and surrogate endpoints pipeline from bench to bedside: A translational perspective

A biomarker is a qualitative and quantitative biological substance or characteristic that defines a certain pathological condition and may give indications on disease severity and the type of therapy that should be administered to the patient. Traumatic brain injury (TBI) is an ever-growing public health concern, where the annual number of TBI patients reaches a staggering number of around 1.7 million cases in the United States alone. It is important that we continue the pursuit for the ideal TBI biomarker in order to decrease the number of fatalities secondary to TBI, and its direct and indirect costs. However, the path towards reaching a surrogate endpoint biomarker is not easy but rather long and needs time and effort. In this chapter, we discuss the process of assessment and validation through which a biomarker passes through in order to be finally established as a TBI biomarker and approved by the FDA. We also provide a brief history on TBI biomarkers, discuss the different types and sources of biomarkers and give a summary of TBI biomarkers currently in use and their potential clinical application.