A pathway and approach to biomarker validation and qualification for osteoarthritis clinical trials.
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.
Hunter
David J
DJ
Division of Research, New England Baptist Hospital, 125 Parker Hill Ave, Boston MA 02120, USA. djhunter@caregroup.harvard.edu
Losina
Elena
E
Guermazi
Ali
A
Burstein
Deb
D
Lassere
Marissa N
MN
Kraus
Virginia
V
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
D015415:Biomarkers