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HSS Journal

, Volume 8, Issue 1, pp 64–65 | Cite as

Patient Evaluation and OA Study Design: OARSI/Biomarker Qualification

  • Virginia Byers KrausEmail author
HSS Osteoarthritis Symposium: Frontiers in OA

Introduction

Qualification is defined as the “graded, ‘fit-for-purpose’ evidentiary process linking a biomarker with biology and clinical endpoints” [5]. 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” [3].

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...

Keyword

biomarkers osteoarthritis FDA qualification drug development tools 

Notes

Acknowledgments

The author wishes to acknowledge NIH NIAMS PO1 AR050245, NIA Claude D. Pepper Older Americans Independence Centers 5P30 AG028716, and NIA R21 AG039782-01 for funding support.

Disclosures

The author certifies that he or she has no commercial associations (e.g., consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article.

References

  1. 1.
    Colman, E. G. 2003. The Food and Drug Administration's Osteoporosis Guidance Document: past, present, and future. J Bone Miner Res, 18, 1125–8.PubMedCrossRefGoogle Scholar
  2. 2.
    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.PubMedCrossRefGoogle Scholar
  3. 3.
    FDA, F. A. D. A. 2010. Guidance for Industry: Qualification Process for Drug Development Tools. October.Google Scholar
  4. 4.
    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.Google Scholar
  5. 5.
    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.PubMedCrossRefGoogle Scholar

Copyright information

© Hospital for Special Surgery 2011

Authors and Affiliations

  1. 1.Duke University Medical CenterDurhamUSA

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