A Pathway and Approach to Biomarker Validation and Qualification for Osteoarthritis Clinical Trials

David      J. Hunter; Elena      Losina; Ali      Guermazi; Deb      Burstein; Marissa      N. Lassere; Virginia      Kraus

doi:10.2174/138945010791011947

Abstract

This narrative review outlines the work done in other fields with regards biomarker validation and qualification and the lessons that we may learn from this experience. Defining a universally agreed upon path for biomarker validation and qualification is urgently needed to circumvent many of the hurdles faced in OA therapeutic development irrespective of whether we are discussing biochemical markers, imaging markers or other measures. This review proposes a path that may be suitable for osteoarthritis and poses some logical next steps that will take us in this direction.

Keywords: Osteoarthritis, biomarkers, imaging, biochemical marker, validation, qualification, intervention, surrogate