骨关节炎中可溶性生物标志物的发展：从发现到个性化医疗。
Soluble biomarkers development in osteoarthritis: from discovery to personalized medicine.
作者信息
Henrotin Yves, Sanchez Christelle, Cornet Anne, Van de Put Joachim, Douette Pierre, Gharbi Myriam
机构信息
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 .
出版信息
Biomarkers. 2015;20(8):540-6. doi: 10.3109/1354750X.2015.1123363.
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.
背景
特定的可溶性生物标志物可能是骨关节炎（OA）患者诊断、预后评估及个性化管理的宝贵工具。
目的
描述可溶性生物标志物从发现到临床验证以及监管机构认可用于OA相关生物标志物鉴定的发展路径。
方法与结果
本综述总结了目前关于生物标志物在OA临床试验中的应用指南及其在五个阶段（包括临床前开发以及1期至4期试验）的效用。还介绍了所有可用的监管要求。
结论
采用特定的可溶性生物标志物用于OA的道路虽艰难，但因其能带来益处，所以值得挑战。
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