Biomarkers Definitions Working Group

Association of American Universities (2000). Task Force on Research Accountability Report on University Protection of Human Beings Who are the Subjects of Research. Washington, D.C., June 28, 2000. www.aau.edu/HumSUbRpt06.28.00pdf Biomarkers Definitions Working Group (2001). Biomarkers and surrogate endpoints Preferred definitions and conceptual frameworks. Clin. Pharmacol. Ther. 69 89-95. 

Source Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints preferred definitions and conceptual framework, Clinical Pharmacology and Therapeutics 69 89-95 (2001). 

Biomarkers Definitions Working Group 2001 Biomarkers and surrogate endpoints preferred definitions and conceptual framework. Clinical Pharmacology and Therapeutics 69 89-95 Bland J M, Altman D G 2000 Statistical notes. The odds ratio. British Medical Journal 320 1468 Chalmers 11995 What do I want from health research and researchers when I am a patient British Medical Journal 310 1315-1318 Chatellier G et al 1996 The numbers needed to treat a clinically useful nomogram in its proper context. British Medical Journal 312 426-429 Doll R1998 Controlled trials the 1948 watershed. British Medical Journal 317 1217 (and following articles). 

The Biomarkers Definitions Working Group (BDWG) has stated One approach to the achievement of more expeditious and informative therapeutic research is the use of clinical measurement tools to determine disease progression and the... 

Since laboratory measurements commenced, we have used biomarkers however, in the last decade there has been a great deal of discussion and debate about the term biomarker, its definition, and its usage (Colburn 1997 Biomarkers Definitions Working Group 2001 Frank and Hargreaves 2003). The term biomarker is often used to encompass relatively new indices—for example, plasma and urine profiles obtained with nuclear magnetic resonance spectroscopy (NMR), metabonomics, proteomics, etc. (Grandjean et al. 1994 Timbrell, Draper, and Waterheld 1994). However, the term is equally applicable to the traditional core tests. 

Per definitions provided by the U.S. National Institutes of Health expert working group, a biological marker (biomarker) is a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacological responses to a... 

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