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Abstract
Context: 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.
Methods and 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.
Acknowledgements
The authors would like to thank Dr Christelle Boileau for her assistance in manuscript preparation.
Declaration of interest
YH is the founder and the President of Artialis SA and Synolyne Pharma, two spin-off companies of the University of Liège. He has also received consulting fees from Nestle and Tilman SA, LABHRA and speaking fees from BioIberica, Royal Canin, Expanscience, AC, JVDP and MG are employes of Artialis S.A.