6533b86ffe1ef96bd12cd428
RESEARCH PRODUCT
Harmonization of Immune Biomarker Assays for Clinical Studies
Cedrik M. BrittenChristian OttensmeierCécile GouttefangeasPedro RomeroMarij J. P. WeltersAxel HoosMichael KalosSylvia JanetzkiSjoerd H. Van Der Burgsubject
Protocol (science)ImmunoassayClinical Trials as TopicData variabilitybusiness.industryOperating proceduresHarmonizationGeneral MedicineComputational biologyBioinformaticsClinical trialImmune systemBiomarker (medicine)MedicineHumansbusinessBiomarkersdescription
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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2011-11-09 |