title: A pathway and approach to biomarker validation and qualification for osteoarthritis clinical trials.
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.
authors.affiliation: Division of Research, New England Baptist Hospital, 125 Parker Hill Ave, Boston MA 02120, USA. djhunter@caregroup.harvard.edu
authors.forename: David J
authors.initials: DJ
authors.lastname: Hunter
authors.forename: Elena
authors.initials: E
authors.lastname: Losina
authors.forename: Ali
authors.initials: A
authors.lastname: Guermazi
authors.forename: Deb
authors.initials: D
authors.lastname: Burstein
authors.forename: Marissa N
authors.initials: MN
authors.lastname: Lassere
authors.forename: Virginia
authors.initials: V
authors.lastname: Kraus
mesh_terms: D015415:Biomarkers; D002986:Clinical Trials as Topic / Q000379:methods*; D055808:Drug Discovery / Q000592:standards*; D004335:Drug and Narcotic Control; D006801:Humans; D017146:Models, Organizational; D010003:Osteoarthritis / Q000378:metabolism*; D016896:Treatment Outcome; D054928:Validation Studies as Topic
chemical_list: D015415:Biomarkers