Patient Evaluation and OA Study Design: OARSI/Biomarker Qualification
- Virginia Byers Kraus MD, PhD
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Qualification is defined as the “graded, ‘fit-for-purpose’ evidentiary process linking a biomarker with biology and clinical endpoints” . As recently defined by the Federal Drug Administration (FDA), “qualification is a conclusion that within the stated context (manner and purpose) of use, the results of assessment with a drug development tool (DDT) can be relied upon to have a specific interpretation and application in drug development and regulatory decision making” .
Biomarkers of OA
However, currently there are no FDA-qualified osteoarthritis (OA) biomarkers. All OA biomarkers in current use are for research use only. There are two biomarkers, NTX1 and CTX1, used in osteoporosis research and clinical monitoring that are in fact in vitro diagnostics for osteoporosis. These, along with the advent, in 1979, of dual-energy photon absorptiometry as an FDA-approved method for quantifying bone mass of the spine, led to the rapid development of effective osteoporosis drugs ...
- Colman, E. G. 2003. The Food and Drug Administration's Osteoporosis Guidance Document: past, present, and future. J Bone Miner Res, 18, 1125–8. CrossRef
- Conaghan, P. G., Hunter, D. J., Maillefert, J. F., Reichmann, W. M. & Losina, E. 2011. Summary and recommendations of the OARSI FDA osteoarthritis Assessment of Structural Change Working Group. Osteoarthritis Cartilage, 19, 606–10. CrossRef
- FDA, F. A. D. A. 2010. Guidance for Industry: Qualification Process for Drug Development Tools. October.
- Kraus, V. B., Burnett, B., Coindreau, J., Cottrell, S., Eyre, D., Gendreau, M., Gardiner, J., Garnero, P., Hardin, J., Henrotin, Y., Heinegard, D., Ko, A., Lohmander, S., Matthews, G., Menetski, J., Moskowitz, R., Persiani, S., Poole, R., Rousseau, J. C. & Todman, M. 2011. Application of biomarkers in the development of drugs intended for the treatment of osteoarthritis. Osteoarthritis Cartilage.
- Wagner, J. A., Williams, S. A. & Webster, C. J. 2007. Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs. Clin Pharmacol Ther, 81, 104–7. CrossRef
- Patient Evaluation and OA Study Design: OARSI/Biomarker Qualification
Volume 8, Issue 1 , pp 64-65
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- drug development tools
- Author Affiliations
- 1. Duke University Medical Center, Box 3416, Durham, NC, 27710, USA