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Figure 1. Guiding Principles for Biomarker Research: Phases of Early Detection Research
* Figure 1 from National Cancer Institute, Division of Cancer Prevention. The Early Detection Research Network:
Translational Research to Identify Early Cancer and Cancer Risk. Third Report. March 2005. p15.
Chart showing progression of Guiding Principles for Biomarker Research:
- Phase 1, Preclinical Exploratory; Exploratory studies to identify potentially useful biomarkers.
- Phase 2: Clinical Assay and Validation; Studies to determine the capacity of biomarkers to distinguish between people with cancer and those without.
- Phase 3: Retrospective Longitudinal; Determine how well biomarkers detect preclinical disease by testing the markers against tissues collected longitudinally from research cohorts.
- Phase 4: Prospective Screening; Identify the extent and characteristics of disease detected by the test and determine the false referral rate.
- Phase 5: Cancer Control; Evaluate both the role of the biomarkers for detection of cancer and the overall impact of screening on the population through large-scale population studies.
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