Harmonization of Immune Biomarker Assays for Clinical Studies

被引：75

作者：

van der Burg, Sjoerd H. ^{[1
]}

Kalos, Michael ^{[2
]}

Gouttefangeas, Cecile ^{[3
]}

Janetzki, Sylvia ^{[4
]}

Ottensmeier, Christian ^{[5
]}

Welters, Marij J. P. ^{[1
]}

Romero, Pedro ^{[6
]}

Britten, Cedrik M. ^{[7
,8
]}

Hoos, Axel ^{[9
]}

机构：

[1] Leiden Univ, Dept Clin Oncol, Med Ctr, Leiden, Netherlands

[2] Univ Penn, Dept Pathol & Lab Med, Translat & Correlat Studies Lab, Perelman Sch Med, Philadelphia, PA 19104 USA

[3] Univ Tubingen, Dept Immunol, Inst Cell Biol, D-72076 Tubingen, Germany

[4] ZellNet Consulting Inc, Ft Lee, NJ 07024 USA

[5] Univ Southampton, Expt Canc Med Ctr, Southampton SO16 6YD, Hants, England

[6] Univ Lausanne, Ludwig Ctr Canc Res, CH-1011 Lausanne, Switzerland

[7] Johannes Gutenberg Univ Mainz, Dept Med, Mainz, Germany

[8] Ribological GmbH, D-55101 Mainz, Germany

[9] Bristol Myers Squibb Co, Global Clin Res, Oncol, Wallingford, CT 06492 USA

来源：

SCIENCE TRANSLATIONAL MEDICINE | 2011年 / 3卷 / 108期

关键词：

CANCER VACCINE CONSORTIUM; IMMUNOTHERAPY TRIALS; PROSTATE-CANCER; END-POINTS; GUIDELINES; PARADIGM; SUCCESS; QUALITY; MODEL; PANEL;

D O I：

10.1126/scitranslmed.3002785

中图分类号：

Q2 [细胞生物学];

学科分类号：

071009 ; 090102 ;

摘要：

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.

引用

页数：5

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