title: OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis.
abstract: The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety of reasons but in particular, to determine whether biomarkers are useful in identifying those individuals most likely to receive clinically important benefits from an intervention; and to determine whether biomarkers are useful for identifying individuals at earlier stages of OA in order to institute treatment at a time more amenable to disease modification.
authors.affiliation: Duke Molecular Physiology Institute and Division of Rheumatology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA. Electronic address: vbk@duke.edu.
authors.forename: V B
authors.initials: VB
authors.lastname: Kraus
authors.affiliation: Grupo de Proteomica, ProteoRed/ISCIII, Servicio de Reumatologia, Instituto de Investigación Biomedica de A Coruña (INIBIC), Complexo Hospitalario Universitario de A Coruña (CHUAC), Sergas, Universidade da Coruña (UDC), As Xubias, 15006 A Coruña, Spain.
authors.forename: F J
authors.initials: FJ
authors.lastname: Blanco
authors.affiliation: Orthopedics, Clinical Sciences Lund, Lund University, Lund, Sweden; Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, Boston University, MA, USA.
authors.forename: M
authors.initials: M
authors.lastname: Englund
authors.affiliation: Bone and Cartilage Research Unit, Arthropôle Liège, University of Liège, CHU Sart-Tilman, 4000 Liège, Belgium; Department of Physical Therapy and Rehabilitation, Princess Paola Hospital, Marche-en-Famenne, Belgium.
authors.forename: Y
authors.initials: Y
authors.lastname: Henrotin
authors.affiliation: Department of Orthopedics, Clinical Sciences Lund, Lund University, Lund, Sweden; Research Unit for Musculoskeletal Function and Physiotherapy, and Department of Orthopedics and Traumatology, University of Southern Denmark, Odense, Denmark.
authors.forename: L S
authors.initials: LS
authors.lastname: Lohmander
authors.affiliation: Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, USA.
authors.forename: E
authors.initials: E
authors.lastname: Losina
authors.affiliation: Molecular Skeletal Biology, Department of Clinical Sciences Lund, Lund University, Sweden.
authors.forename: P
authors.initials: P
authors.lastname: Önnerfjord
authors.affiliation: Department of Translational Sciences and Pharmacokinetics, Rottapharm Biotech, Monza, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Persiani
mesh_terms: D015415:Biomarkers / Q000097:blood*; D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D010003:Osteoarthritis / Q000097:blood* / Q000628:therapy*; D017410:Practice Guidelines as Topic / Q000592:standards*
chemical_list: D015415:Biomarkers
keywords: Biomarkers; Clinical trials; Guidelines; Osteoarthritis