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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.

DOI:10.2174/138945010791011947
PMID:20199395
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3261486/
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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8003/3261486/b1b35fef8933/nihms348769f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8003/3261486/b1b35fef8933/nihms348769f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8003/3261486/b1b35fef8933/nihms348769f1.jpg

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本文引用的文献

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Strategic paths for biomarker qualification.生物标志物鉴定的战略路径。
Toxicology. 2008 Mar 20;245(3):219-23. doi: 10.1016/j.tox.2007.12.023. Epub 2008 Jan 6.
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The Biomarkers Consortium: on the critical path of drug discovery.生物标志物联盟:处于药物研发的关键路径上。
神经退行性疾病临床药物研发中的生物标志物引导决策
Nat Rev Drug Discov. 2025 Apr 4. doi: 10.1038/s41573-025-01165-w.
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Regulatory, Translational, and Operational Considerations for the Incorporation of Biomarkers in Drug Development.药物研发中生物标志物纳入的监管、转化及操作考量
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A scoping review of factors influencing the implementation of liquid biopsy for cancer care.一项关于影响癌症护理中液体活检实施的因素的范围综述。
J Exp Clin Cancer Res. 2025 Feb 12;44(1):50. doi: 10.1186/s13046-025-03322-w.
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Associations of Longitudinal Multiparametric MRI Findings and Clinical Outcomes in Intra-Articular Injections for Knee Osteoarthritis.膝关节骨关节炎关节内注射的纵向多参数MRI表现与临床结果的相关性
Diagnostics (Basel). 2024 Sep 13;14(18):2025. doi: 10.3390/diagnostics14182025.
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Rev Cient Odontol (Lima). 2024 Jun 27;12(2):e199. doi: 10.21142/2523-2754-1202-2024-199. eCollection 2024 Apr-Jun.
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