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Abstract:
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In the recently published BEST (Biomarker, EndpointS, and other Tools) glossary, which built in flexibility when possible and appropriate to accommodate different stakeholder needs, biomarker is defined as a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions (https://www.ncbi.nlm.nih.gov/books/NBK338448/#IX-B). Response biomarker and surrogate endpoint are also defined with the same intent to address different stakeholder needs in the BEST glossary. In this presentation, evolution of statistical approaches for response biomarker versus surrogate endpoints validation will be given focusing on newer methodological rationales and advances over time in reference to historical approaches including the well-known Prentice criteria.
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