RT Journal Article SR Electronic T1 Immune monitoring technology primer: clinical validation for predictive markers JF Journal for ImmunoTherapy of Cancer JO J Immunother Cancer FD BMJ Publishing Group Ltd SP 40 DO 10.1186/s40425-015-0086-9 VO 3 IS 1 A1 Kevin K. Dobbin YR 2015 UL http://jitc.bmj.com/content/3/1/40.abstract AB 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.An erratum to this article can be found at http://dx.doi.org/10.1186/s40425-015-0100-2.