A road map to biomarker discovery and validation in urological chronic pelvic pain syndrome.

摘要

Biomarkers and surrogate end points are important tools in the diagnostic and therapeutic armamentarium. By definition a biomarker is a biological characteristic that is measured and evaluated objectively as an indicator of normal biological or pathogenic processes (a diagnostic biomarker), or a pharmacological response to therapeutic intervention (a therapeutic biomarker). Thus, any patient parameter that can be measured, for example, mRNA expression profiles, proteomic signatures, protein or lipid levels, imaging methods or electrical signals, may serve as a biomarker. The best biomarkers are accurate, relatively noninvasive and easy to perform tests that can be done at the bedside or in the outpatient setting. In contrast, a surrogate end point marker is the rare biomarker that can substitute (or be a surrogate) for a clinical end point such as survival, stroke, fracture or cancer recurrence. CD4 counts are typically used as surrogate end point markers in the treatment of patients with HIV.