title: Harmonization of immune biomarker assays for clinical studies.
abstract: Assays that measure a patient's immune response play an increasingly important role in the development of immunotherapies. The inherent complexity of these assays and independent protocol development between laboratories result in high data variability and poor reproducibility. Quality control through harmonization--based on integration of laboratory-specific protocols with standard operating procedures and assay performance benchmarks--is one way to overcome these limitations. Harmonization guidelines can be widely implemented to address assay performance variables. This process enables objective interpretation and comparison of data across clinical trial sites and also facilitates the identification of relevant immune biomarkers, guiding the development of new therapies.
authors.affiliation: Department of Clinical Oncology, Leiden University Medical Center, Leiden, Netherlands.
authors.forename: Sjoerd H
authors.initials: SH
authors.lastname: van der Burg
authors.forename: Michael
authors.initials: M
authors.lastname: Kalos
authors.forename: Cécile
authors.initials: C
authors.lastname: Gouttefangeas
authors.forename: Sylvia
authors.initials: S
authors.lastname: Janetzki
authors.forename: Christian
authors.initials: C
authors.lastname: Ottensmeier
authors.forename: Marij J P
authors.initials: MJ
authors.lastname: Welters
authors.forename: Pedro
authors.initials: P
authors.lastname: Romero
authors.forename: Cedrik M
authors.initials: CM
authors.lastname: Britten
authors.forename: Axel
authors.initials: A
authors.lastname: Hoos
mesh_terms: D015415:Biomarkers / Q000378:metabolism*; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D007118:Immunoassay / Q000379:methods* / Q000592:standards*
chemical_list: D015415:Biomarkers