| 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 |
