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

Kraus, V B; Blanco, F J; Englund, M; Henrotin, Y; Lohmander, Stefan LU ; Losina, E; Önnerfjord, Patrik LU and Persiani, S (2015) In Osteoarthritis and Cartilage 23(5). p.686-697
Abstract
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... (More)
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. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Osteoarthritis and Cartilage
volume
23
issue
5
pages
686 - 697
publisher
Elsevier
external identifiers
  • pmid:25952342
  • wos:000353821200004
  • scopus:84933524746
ISSN
1063-4584
DOI
10.1016/j.joca.2015.03.002
language
English
LU publication?
yes
id
74a4dce6-eda4-4327-b999-51840e9dc5fd (old id 5456710)
alternative location
http://www.ncbi.nlm.nih.gov/pubmed/25952342?dopt=Abstract
date added to LUP
2015-06-02 15:32:14
date last changed
2017-11-12 03:06:45
@article{74a4dce6-eda4-4327-b999-51840e9dc5fd,
  abstract     = {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.},
  author       = {Kraus, V B and Blanco, F J and Englund, M and Henrotin, Y and Lohmander, Stefan and Losina, E and Önnerfjord, Patrik and Persiani, S},
  issn         = {1063-4584},
  language     = {eng},
  number       = {5},
  pages        = {686--697},
  publisher    = {Elsevier},
  series       = {Osteoarthritis and Cartilage},
  title        = {OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis.},
  url          = {http://dx.doi.org/10.1016/j.joca.2015.03.002},
  volume       = {23},
  year         = {2015},
}