Immune monitoring technology primer: clinical validation for predictive markers

Abstract

BackgroundRecent 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.FindingsThe 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.ConclusionsClinical validation of immunology biomarkers can be demanding both in terms of time and resources, and careful planning and study design are critical.

Erratum to: Immune monitoring technology primer

“…The title of the original version of this article [ 1 ] contained an error. The correct title should be “Immune Monitoring Technology Primer: Clinical Validation for Predictive Markers.” The title has been corrected in the original article also.…”