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Copyright ©2014 Baishideng Publishing Group Inc.
World J Gastrointest Pathophysiol. Nov 15, 2014; 5(4): 450-456
Published online Nov 15, 2014. doi: 10.4291/wjgp.v5.i4.450
Table 1 Phases of biomarker production
Phases of biomarker validation and development
Phase 1: Biomarkers of promise are identified based on application in other cancers and elucidation of novel pathways
Phase 2: Cross-sectional studies validate the biomarker of interest to be sufficiently discriminatory and biomarker assays are standardized
Phase 3: Case-control studies with a retrospective but longitudinal design confirm the biomarker is expressed before the development of cancer
Phase 4: Prospective longitudinal studies avoid biases associated with case-control studies
Phase 5: Population-based studies show the impact of biomarker detection on disease burden and cancer control