用于骨关节炎临床试验的生物标志物验证和确证的途径和方法。
A pathway and approach to biomarker validation and qualification for osteoarthritis clinical trials.
机构信息
Division of Research, New England Baptist Hospital, 125 Parker Hill Ave, Boston MA 02120, USA.
出版信息
Curr Drug Targets. 2010 May;11(5):536-45. doi: 10.2174/138945010791011947.
Abstract
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.
摘要
这篇叙述性综述概述了在其他领域中关于生物标志物验证和确证所做的工作，以及我们可以从中吸取的经验教训。无论我们讨论的是生化标志物、影像学标志物还是其他指标，都迫切需要为生物标志物验证和确证定义一个普遍达成共识的途径，以避免在骨关节炎治疗开发中遇到的许多障碍。本综述提出了一条可能适用于骨关节炎的途径，并提出了一些合乎逻辑的下一步措施，将我们引向这一方向。
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