Hunter David J, Nevitt Michael, Losina Elena, Kraus Virginia
Department of Rheumatology, Royal North Shore Hospital and Northern Clinical School, Kolling Institute, University of Sydney, Reserve Road, St Leonards, Sydney, NSW 2065, Australia.
Department of Epidemiology and Biostatistics, OAI Coordinating Ctr., University of California, San Francisco (UCSF), San Francisco, CA, USA.
Best Pract Res Clin Rheumatol. 2014 Feb;28(1):61-71. doi: 10.1016/j.berh.2014.01.007.
Historically disease knowledge development and treatment innovation in osteoarthritis (OA) has been considered to be slow. One of the many reasons purported as responsible for this slow pace has been the alleged lack of valid and responsive biomarkers to ascertain efficacy, which itself has been dependent upon the slow evolution of the understanding of the complex nature of joint tissue biology. This narrative review outlines the rationale for why we need OA biomarkers with regard to biomarker validation and qualification. The main biomarkers in current development for OA are biochemical and imaging markers. We describe an approach to biomarker validation and qualification for OA clinical trials that has recently commenced with the Foundation of NIH OA Biomarkers Consortium study cosponsored by the Osteoarthritis Research Society International (OARSI). With this approach we endeavor to identify, develop, and qualify biological markers (biomarkers) to support new drug development, preventive medicine, and medical diagnostics for osteoarthritis.
从历史上看，骨关节炎（OA）的疾病知识发展和治疗创新一直被认为进展缓慢。造成这种缓慢进展的众多原因之一据称是缺乏用于确定疗效的有效且灵敏的生物标志物，而这本身又依赖于对关节组织生物学复杂性质的理解的缓慢演变。这篇叙述性综述概述了就生物标志物验证和鉴定而言我们为何需要骨关节炎生物标志物的基本原理。目前正在研发的用于骨关节炎的主要生物标志物是生化标志物和成像标志物。我们描述了一种用于骨关节炎临床试验的生物标志物验证和鉴定方法，该方法最近已随着由国际骨关节炎研究学会（OARSI）共同赞助的美国国立卫生研究院骨关节炎生物标志物联盟研究基金会的研究而启动。通过这种方法，我们致力于识别、开发和鉴定生物标志物，以支持骨关节炎的新药研发、预防医学和医学诊断。
