OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis

被引：57
|
作者：
Kraus, V. B. [1 ]
Blanco, F. J. [2 ]
Englund, M. [3 ,4 ]
Henrotin, Y. [5 ,6 ]
Lohmander, L. S. [7 ,8 ,9 ]
Losina, E. [10 ]
Onnerfjord, P. [11 ]
Persiani, S. [12 ]
机构：
[1] Duke Univ, Sch Med, Dept Med, Div Rheumatol, Durham, NC 27706 USA
[2] UDC, CHUAC, Inst Invest Biomed A Coruna INIBIC, Grp Prote,ProteoRed ISCIII,Serv Reumatol,Sergas, As Xubias 15006, A Coruna, Spain
[3] Lund Univ, Clin Sci Lund, Orthoped, Lund, Sweden
[4] Boston Univ, Sch Med, Clin Epidemiol Res & Training Unit, Boston, MA 02215 USA
[5] Univ Liege, CHU Sart Tilman, Arthropole Liege, Bone & Cartilage Res Unit, B-4000 Liege, Belgium
[6] Princess Paola Hosp, Dept Phys Therapy & Rehabil, Marche En Famenne, Belgium
[7] Lund Univ, Clin Sci Lund, Dept Orthoped, Lund, Sweden
[8] Univ Southern Denmark, Res Unit Musculoskeletal Funct & Physiotherapy, Odense, Denmark
[9] Univ Southern Denmark, Dept Orthoped & Traumatol, Odense, Denmark
[10] Harvard Univ, Brigham & Womens Hosp, Sch Med, Orthoped & Arthrit Ctr Outcomes Res,Dept Orthoped, Boston, MA 02115 USA
[11] Lund Univ, Dept Clin Sci Lund, Mol Skeletal Biol, Lund, Sweden
[12] Rottapharm Biotech, Dept Translat Sci & Pharmacokinet, Monza, Italy
来源：
OSTEOARTHRITIS AND CARTILAGE | 2015年 / 23卷 / 05期
基金：
美国国家卫生研究院;
关键词：
Biomarkers; Osteoarthritis; Clinical trials; Guidelines; SURROGATE END-POINTS; PLASMA-PROTEOME-PROJECT; DRUG DEVELOPMENT; GLOBAL BURDEN; FIBRONECTIN FRAGMENTS; RESEARCH-SOCIETY; RECEPTOR THEORY; SYNOVIAL-FLUID; DISEASE; 2010; CARTILAGE;
D O I：
10.1016/j.joca.2015.03.002
中图分类号：
R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学（修复外科学）];
学科分类号：
摘要：
The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety of reasons but in particular, to determine whether biomarkers are useful in identifying those individuals most likely to receive clinically important benefits from an intervention; and to determine whether biomarkers are useful for identifying individuals at earlier stages of OA in order to institute treatment at a time more amenable to disease modification. (C) 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.
引用
收藏
页码：686 / 697
页数：12
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