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Development of draft validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting structural damage endpoints in rheumatoid arthritis and spondyloarthritis clinical trials

Maksymowych, Walter P.; Landewe, Robert; Boers, Maarten; Garnero, Patrick; Geusens, Piet; El-Gabalawy, Hani; Heinegård, Dick LU ; Krause, Virginia; Lohmander, Stefan LU and Matyas, John, et al. (2007) In Journal of Rheumatology 34(3). p.634-640
Abstract
Objective. Recent work has shown that several soluble biomarkers, detectable in peripheral blood, synovial fluid, and/or urine, reflect remodeling of joint tissues and may therefore constitute outcome measures that reflect joint damage. Consequently, it is now desirable to begin the process of developing criteria for validation of a soluble biomarker as an outcome measure reflecting structural damage progression in trials of disease-modifying therapies for rheumatoid arthritis (RA) and spondyloarthritis (SpA). Our objective was to develop validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting radiological endpoints in RA and SpA clinical trials. Methods. A special interest group was established... (More)
Objective. Recent work has shown that several soluble biomarkers, detectable in peripheral blood, synovial fluid, and/or urine, reflect remodeling of joint tissues and may therefore constitute outcome measures that reflect joint damage. Consequently, it is now desirable to begin the process of developing criteria for validation of a soluble biomarker as an outcome measure reflecting structural damage progression in trials of disease-modifying therapies for rheumatoid arthritis (RA) and spondyloarthritis (SpA). Our objective was to develop validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting radiological endpoints in RA and SpA clinical trials. Methods. A special interest group was established comprising investigators with expertise in soluble biomarker assay development as well as in outcomes research. This project was initiated by means of a Delphi consensus exercise. A list of draft criteria was first generated following a review of a US National Institutes of Health (NIH) 2000 white paper (available at: http://www.niams.nih.gov/ne/oi/ oabiomarwhipap.htm) that focused on biomarkers in OA, and these were organized under subject headings relevant to the OMERACT filter: truth, discrimination, and feasibility. Additional criteria were solicited from the working group. This was followed by 3 rounds of voting. Results. A list of 31 criteria was generated prior to voting. The first 2 rounds of voting resulted in cumulative agreement that 19 criteria be retained and 4 discarded, while discrepancies were recorded for 8 criteria. In the third round of voting, cumulative agreement was achieved to retain 5 of the 8 discrepant criteria, so that the final list included 24 criteria. Conclusion. A draft set of criteria for validation of a soluble biomarker to be regarded as reflecting radiological damage endpoints in clinical trials has been proposed on the basis of consensus. (Less)
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Contribution to journal
publication status
published
subject
keywords
criteria, validation, spondyloarthritis, biomarker, rheumatoid arthritis, OMERACT, structural damage
in
Journal of Rheumatology
volume
34
issue
3
pages
634 - 640
publisher
J Rheumatol Publ Co
external identifiers
  • wos:000244613800030
  • scopus:33847619751
ISSN
0315-162X
language
English
LU publication?
yes
id
89ab42af-7c5e-4e3e-8ccb-08cf5d26c831 (old id 672581)
date added to LUP
2007-12-14 14:59:48
date last changed
2017-01-01 05:14:39
@article{89ab42af-7c5e-4e3e-8ccb-08cf5d26c831,
  abstract     = {Objective. Recent work has shown that several soluble biomarkers, detectable in peripheral blood, synovial fluid, and/or urine, reflect remodeling of joint tissues and may therefore constitute outcome measures that reflect joint damage. Consequently, it is now desirable to begin the process of developing criteria for validation of a soluble biomarker as an outcome measure reflecting structural damage progression in trials of disease-modifying therapies for rheumatoid arthritis (RA) and spondyloarthritis (SpA). Our objective was to develop validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting radiological endpoints in RA and SpA clinical trials. Methods. A special interest group was established comprising investigators with expertise in soluble biomarker assay development as well as in outcomes research. This project was initiated by means of a Delphi consensus exercise. A list of draft criteria was first generated following a review of a US National Institutes of Health (NIH) 2000 white paper (available at: http://www.niams.nih.gov/ne/oi/ oabiomarwhipap.htm) that focused on biomarkers in OA, and these were organized under subject headings relevant to the OMERACT filter: truth, discrimination, and feasibility. Additional criteria were solicited from the working group. This was followed by 3 rounds of voting. Results. A list of 31 criteria was generated prior to voting. The first 2 rounds of voting resulted in cumulative agreement that 19 criteria be retained and 4 discarded, while discrepancies were recorded for 8 criteria. In the third round of voting, cumulative agreement was achieved to retain 5 of the 8 discrepant criteria, so that the final list included 24 criteria. Conclusion. A draft set of criteria for validation of a soluble biomarker to be regarded as reflecting radiological damage endpoints in clinical trials has been proposed on the basis of consensus.},
  author       = {Maksymowych, Walter P. and Landewe, Robert and Boers, Maarten and Garnero, Patrick and Geusens, Piet and El-Gabalawy, Hani and Heinegård, Dick and Krause, Virginia and Lohmander, Stefan and Matyas, John and Saxne, Tore and van der Heijde, Desiree},
  issn         = {0315-162X},
  keyword      = {criteria,validation,spondyloarthritis,biomarker,rheumatoid arthritis,OMERACT,structural damage},
  language     = {eng},
  number       = {3},
  pages        = {634--640},
  publisher    = {J Rheumatol Publ Co},
  series       = {Journal of Rheumatology},
  title        = {Development of draft validation criteria for a soluble biomarker to be regarded as a valid biomarker reflecting structural damage endpoints in rheumatoid arthritis and spondyloarthritis clinical trials},
  volume       = {34},
  year         = {2007},
}