title: Soluble biomarkers development in osteoarthritis: from discovery to personalized medicine.
abstract: BACKGROUND
  Specific soluble biomarkers could be a precious tool for diagnosis, prognosis and personalized management of osteoarthritic (OA) patients.
  
  
  OBJECTIVE
  To describe the path of soluble biomarker development from discovery to clinical qualification and regulatory adoption toward OA-related biomarker qualification.
  
  
  RESULTS
  This review summarizes current guidance on the use of biomarkers in OA in clinical trials and their utility at five stages, including preclinical development and phase 1 to phase 4 trials. It also presents all the available regulatory requirements.
  
  
  CONCLUSIONS
  The path through the adoption of a specific soluble biomarker for OA is steep but is worth the challenge due to the benefit that it can provide.
authors.affiliation: a Bone and Cartilage Research Unit, Arthropôle Liège, University of Liège, Institute of Pathology , CHU Sart-Tilman , Liège , Belgium .|b Department of Physical Therapy and Rehabilitation , Princess Paola Hospital , Marche-en-Famenne , Belgium .|c GIGA Tower , Liège , Belgium , and.|d Synolyne Pharma , Herstal , Belgium.
authors.forename: Yves
authors.initials: Y
authors.lastname: Henrotin
authors.affiliation: a Bone and Cartilage Research Unit, Arthropôle Liège, University of Liège, Institute of Pathology , CHU Sart-Tilman , Liège , Belgium .
authors.forename: Christelle
authors.initials: C
authors.lastname: Sanchez
authors.affiliation: c GIGA Tower , Liège , Belgium , and.
authors.forename: Anne
authors.initials: A
authors.lastname: Cornet
authors.affiliation: c GIGA Tower , Liège , Belgium , and.
authors.forename: Joachim
authors.initials: J
authors.lastname: Van de Put
authors.affiliation: d Synolyne Pharma , Herstal , Belgium.
authors.forename: Pierre
authors.initials: P
authors.lastname: Douette
authors.affiliation: c GIGA Tower , Liège , Belgium , and.
authors.forename: Myriam
authors.initials: M
authors.lastname: Gharbi
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000378:metabolism*; D002986:Clinical Trials as Topic; D006801:Humans; D010003:Osteoarthritis / Q000175:diagnosis / Q000378:metabolism* / Q000628:therapy; D057285:Precision Medicine / Q000379:methods*; D011237:Predictive Value of Tests; D011379:Prognosis; D015203:Reproducibility of Results; D012995:Solubility
chemical_list: D015415:Biomarkers
keywords: Clinical qualification; drug development tool; personalized healthcare/medicine