Harmonization of immune biomarker assays for clinical studies.

Details

Serval ID
serval:BIB_03DCFBBD2035
Type
Article: article from journal or magazin.
Publication sub-type
Editorial
Collection
Publications
Institution
Title
Harmonization of immune biomarker assays for clinical studies.
Journal
Science Translational Medicine
Author(s)
van der Burg S.H., Kalos M., Gouttefangeas C., Janetzki S., Ottensmeier C., Welters M.J., Romero P., Britten C.M., Hoos A.
ISSN
1946-6242 (Electronic)
ISSN-L
1946-6234
Publication state
Published
Issued date
2011
Volume
3
Number
108
Pages
108ps44
Language
english
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.
Pubmed
Web of science
Create date
16/02/2012 15:19
Last modification date
20/08/2019 12:25
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