Patient Evaluation and OA Study Design: OARSI/Biomarker Qualification

Virginia Byers Kraus, MD, PhD
Duke University Medical Center, Durham, North Carolina


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”.

This article appears in HSS Journal: Volume 8, Number 1.
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About the HSS Journal

HSS Journal, an academic peer-reviewed journal published three times a year, February, July and October. The Journal accepts and publishes peer reviewed articles from around the world that contribute to the advancement of the knowledge of musculoskeletal diseases and disorders.


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