Chapter 1
Nuts and Bolts of Biomarker Research
Sharmistha Ghosh,
Sudhir Srivastava,
Sharmistha Ghosh
Cancer Biomarkers Research Group, Division of Cancer Prevention, National Cancer Institute, Rockville, MD, USA
Search for more papers by this authorSudhir Srivastava
National Cancer Institute, National Institutes of Health, Bethesda, Cancer Biomarkers Research Group, Division of Cancer Prevention, MD, USA
Search for more papers by this authorSharmistha Ghosh,
Sudhir Srivastava,
Sharmistha Ghosh
Cancer Biomarkers Research Group, Division of Cancer Prevention, National Cancer Institute, Rockville, MD, USA
Search for more papers by this authorSudhir Srivastava
National Cancer Institute, National Institutes of Health, Bethesda, Cancer Biomarkers Research Group, Division of Cancer Prevention, MD, USA
Search for more papers by this authorBook Editor(s):Sudhir Srivastava Ph.D, MPH,
Sudhir Srivastava Ph.D, MPH
Search for more papers by this authorFirst published: 09 June 2017
Abstract
This chapter outlines a systematic approach to biomarker development designed to cope effectively with the US regulatory system, under which the products are brought to the market, and also provides an insight into the various available tools that support the discovery and development of biomarkers. The Early Detection Research Network (EDRN) of the National Cancer Institute (NCI), launched in 2000, is the first comprehensive network created to scrupulously discover and validate biomarkers for early detection of cancer. Since its inception, the EDRN has made significant progress in developing a dynamic organized infrastructure for identifying candidate biomarkers, accommodating rapidly evolving technologies, and conducting multicenter validation studies and building resources, while also fostering public-private partnerships (PPPs) with industries, and developing collaborations with other government agencies and designated cancer centers. The Translational Research Working Group (TRWG) of the NCI drafted a biospecimen-based assessment modality pathway (BM Pathway), which sketches out the necessary elements in biomarker development.
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