title: Biomarkers for osteoarthritis: current position and steps towards further validation.
abstract: Historically disease knowledge development and treatment innovation in osteoarthritis (OA) has been considered to be slow. One of the many reasons purported as responsible for this slow pace has been the alleged lack of valid and responsive biomarkers to ascertain efficacy, which itself has been dependent upon the slow evolution of the understanding of the complex nature of joint tissue biology. This narrative review outlines the rationale for why we need OA biomarkers with regard to biomarker validation and qualification. The main biomarkers in current development for OA are biochemical and imaging markers. We describe an approach to biomarker validation and qualification for OA clinical trials that has recently commenced with the Foundation of NIH OA Biomarkers Consortium study cosponsored by the Osteoarthritis Research Society International (OARSI). With this approach we endeavor to identify, develop, and qualify biological markers (biomarkers) to support new drug development, preventive medicine, and medical diagnostics for osteoarthritis.
authors.affiliation: Department of Rheumatology, Royal North Shore Hospital and Northern Clinical School, Kolling Institute, University of Sydney, Reserve Road, St Leonards, Sydney, NSW 2065, Australia. Electronic address: David.Hunter@sydney.edu.au.
authors.forename: David J
authors.initials: DJ
authors.lastname: Hunter
authors.affiliation: Department of Epidemiology and Biostatistics, OAI Coordinating Ctr., University of California, San Francisco (UCSF), San Francisco, CA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Nevitt
authors.affiliation: Orthopaedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
authors.forename: Elena
authors.initials: E
authors.lastname: Losina
authors.affiliation: Department of Medicine, Duke University, Rheumatology & Immunology, Durham, NC, USA.
authors.forename: Virginia
authors.initials: V
authors.lastname: Kraus
mesh_terms: D015415:Biomarkers / Q000378:metabolism*; D006801:Humans; D010003:Osteoarthritis / Q000175:diagnosis* / Q000378:metabolism*; D054928:Validation Studies as Topic
chemical_list: D015415:Biomarkers
keywords: Biomarkers; Osteoarthritis