Abstract
BACKGROUND: Recent biotechnological developments have resulted in increasing interest in immunology biomarkers. These biomarkers have potential clinical utility in the near future as predictors of treatment response. Hence, clinical validation of these predictive markers is critical. FINDINGS: The process of clinically validating a predictive biomarker is reviewed. Validation of a predictive biomarker requires quantifying the strength of a statistical interaction between marker and a treatment. Different study designs are considered. CONCLUSIONS: Clinical validation of immunology biomarkers can be demanding both in terms of time and resources, and careful planning and study design are critical.