How are validities (lifecycles phases) defined in the Biomarkers Knowledge Area?
Recommended/approved: Kit or measuring device/software is approved by the FDA or other government authority, and/or the use of the biomarker is described in clinical practice guidelines or consensus development statements have been issued by clinical societies of international standing. Late studies in humans: The biomarker use has been studied in humans (clinical trials and observational studies) but has not yet been approved by a regulatory authority. Should be studies with over 500 individuals. The objective is to measure efficacy and to establish the relationship found in early studies in humans. Early Studies in Humans: The biomarker use has been studied in humans (clinical trials and observational studies). Should be studies with less than 500 individuals. The objective of these studies is to measure proof of concept and dose finding. Experimental: Reports from preclinical studies (laboratory and/or animal studies). Discontinued: For a biomarker use that is not “Recommended/appro
