Phases Type of studies Outcome
Phase I Preclinical exploration Promising directions are explored and potential biomarkers identified
Phase II Clinical assay and validation Determination of the potential capacity of the biomarker to established disease
Phase III Retrospective longitudinal Determine how well biomarkers
detect pre-clinical disease through retrospectively testing
Phase IV Prospective screening Identify the characteristics of the disease detected by the biomarker and determine the false positive rate
Phase V Cancer control Quantification of  the role of the biomarkers in the reduction of disease burden through Phase 5 population screening
Table 1: Structured phased -model for development evaluation, and validation of biomarkers modified from Pepe et al., and Paradiso et al. [11,13].