Advanced

Application of biomarkers in the development of drugs intended for the treatment of osteoarthritis

Kraus, V. B.; Burnett, B.; Coindreau, J.; Cottrell, S.; Eyre, D.; Gendreau, M.; Gardiner, J.; Garnero, P.; Hardin, J. and Henrotin, Y., et al. (2011) In Osteoarthritis and Cartilage 19(5). p.515-542
Abstract
Objective: Osteoarthritis (OA) is a chronic and slowly progressive disease for which biomarkers may be able to provide a more rapid indication of therapeutic responses to therapy than is currently available; this could accelerate and facilitate OA drug discovery and development programs. The goal of this document is to provide a summary and guide to the application of in vitro (biochemical and other soluble) biomarkers in the development of drugs for OA and to outline and stimulate a research agenda that will further this goal. Methods: The Biomarkers Working Group representing experts in the field of OA biomarker research from both academia and industry developed this consensus document between 2007 and 2009 at the behest of the... (More)
Objective: Osteoarthritis (OA) is a chronic and slowly progressive disease for which biomarkers may be able to provide a more rapid indication of therapeutic responses to therapy than is currently available; this could accelerate and facilitate OA drug discovery and development programs. The goal of this document is to provide a summary and guide to the application of in vitro (biochemical and other soluble) biomarkers in the development of drugs for OA and to outline and stimulate a research agenda that will further this goal. Methods: The Biomarkers Working Group representing experts in the field of OA biomarker research from both academia and industry developed this consensus document between 2007 and 2009 at the behest of the Osteoarthritis Research Society International Federal Drug Administration initiative (OARSI FDA initiative). Results: This document summarizes definitions and classification systems for biomarkers, the current outcome measures used in OA clinical trials, applications and potential utility of biomarkers for development of OA therapeutics, the current state of qualification of OA-related biomarkers, pathways for biomarker qualification, critical needs to advance the use of biomarkers for drug development, recommendations regarding practices and clinical trials, and a research agenda to advance the science of OA-related biomarkers. Conclusions: Although many OA-related biomarkers are currently available they exist in various states of qualification and validation. The biomarkers that are likely to have the earliest beneficial impact on clinical trials fall into two general categories, those that will allow targeting of subjects most likely to either respond and/or progress (prognostic value) within a reasonable and manageable time frame for a clinical study (for instance within 1-2 years for an OA trial), and those that provide early feedback for preclinical decision-making and for trial organizers that a drug is having the desired biochemical effect. As in vitro biomarkers are increasingly investigated in the context of specific drug treatments, advances in the field can be expected that will lead to rapid expansion of the list of available biomarkers with increasing understanding of the molecular processes that they represent. (C) 2011 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved. (Less)
Please use this url to cite or link to this publication:
author
, et al. (More)
(Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Osteoarthritis, Biomarkers, Clinical trial
in
Osteoarthritis and Cartilage
volume
19
issue
5
pages
515 - 542
publisher
Elsevier
external identifiers
  • wos:000291378900007
  • scopus:79955846044
ISSN
1063-4584
DOI
10.1016/j.joca.2010.08.019
language
English
LU publication?
yes
id
0acc7ba6-606d-476a-b543-5a9b1a43884e (old id 1984794)
date added to LUP
2011-07-01 09:12:54
date last changed
2017-09-17 03:38:57
@article{0acc7ba6-606d-476a-b543-5a9b1a43884e,
  abstract     = {Objective: Osteoarthritis (OA) is a chronic and slowly progressive disease for which biomarkers may be able to provide a more rapid indication of therapeutic responses to therapy than is currently available; this could accelerate and facilitate OA drug discovery and development programs. The goal of this document is to provide a summary and guide to the application of in vitro (biochemical and other soluble) biomarkers in the development of drugs for OA and to outline and stimulate a research agenda that will further this goal. Methods: The Biomarkers Working Group representing experts in the field of OA biomarker research from both academia and industry developed this consensus document between 2007 and 2009 at the behest of the Osteoarthritis Research Society International Federal Drug Administration initiative (OARSI FDA initiative). Results: This document summarizes definitions and classification systems for biomarkers, the current outcome measures used in OA clinical trials, applications and potential utility of biomarkers for development of OA therapeutics, the current state of qualification of OA-related biomarkers, pathways for biomarker qualification, critical needs to advance the use of biomarkers for drug development, recommendations regarding practices and clinical trials, and a research agenda to advance the science of OA-related biomarkers. Conclusions: Although many OA-related biomarkers are currently available they exist in various states of qualification and validation. The biomarkers that are likely to have the earliest beneficial impact on clinical trials fall into two general categories, those that will allow targeting of subjects most likely to either respond and/or progress (prognostic value) within a reasonable and manageable time frame for a clinical study (for instance within 1-2 years for an OA trial), and those that provide early feedback for preclinical decision-making and for trial organizers that a drug is having the desired biochemical effect. As in vitro biomarkers are increasingly investigated in the context of specific drug treatments, advances in the field can be expected that will lead to rapid expansion of the list of available biomarkers with increasing understanding of the molecular processes that they represent. (C) 2011 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.},
  author       = {Kraus, V. B. and Burnett, B. and Coindreau, J. and Cottrell, S. and Eyre, D. and Gendreau, M. and Gardiner, J. and Garnero, P. and Hardin, J. and Henrotin, Y. and Heinegård, Dick and Ko, A. and Lohmander, Stefan and Matthews, G. and Menetski, J. and Moskowitz, R. and Persiani, S. and Poole, A. R. and Rousseau, J. -C. and Todman, M.},
  issn         = {1063-4584},
  keyword      = {Osteoarthritis,Biomarkers,Clinical trial},
  language     = {eng},
  number       = {5},
  pages        = {515--542},
  publisher    = {Elsevier},
  series       = {Osteoarthritis and Cartilage},
  title        = {Application of biomarkers in the development of drugs intended for the treatment of osteoarthritis},
  url          = {http://dx.doi.org/10.1016/j.joca.2010.08.019},
  volume       = {19},
  year         = {2011},
}