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. Author manuscript; available in PMC: 2023 May 30.
Published in final edited form as: J Hepatol. 2022 Sep 8;78(1):207–216. doi: 10.1016/j.jhep.2022.08.036

Fig. 1. Phases of biomarker validation.

Fig. 1.

(A) Phase I - preclinical exploratory to identify candidate biomarkers; (B) Phase II – clinical assay validation using a case-control design; (C) Phase III – longitudinal prospective-specimen collection in at-risk patients, with retrospective blinded-evaluation of biomarker performance; (D) Phase IV - prospective cohort studies or clinical utility trial where the biomarker is tested against a gold standard; (E) Phase V – cancer control studies to determine the impact of biomarker screening on cancer mortality. HCC, hepatocellular carcinoma.