A Pathway and Approach to Biomarker Validation and Qualification for Osteoarthritis Clinical Trials

Title: A Pathway and Approach to Biomarker Validation and Qualification for Osteoarthritis Clinical Trials

Volume: 11 Issue: 5

Author(s): David J. Hunter, Elena Losina, Ali Guermazi, Deb Burstein, Marissa N. Lassere and Virginia Kraus

Affiliation:

Keywords: Osteoarthritis, biomarkers, imaging, biochemical marker, validation, qualification, intervention, surrogate

Abstract: This narrative review outlines the work done in other fields with regards biomarker validation and qualification and the lessons that we may learn from this experience. Defining a universally agreed upon path for biomarker validation and qualification is urgently needed to circumvent many of the hurdles faced in OA therapeutic development irrespective of whether we are discussing biochemical markers, imaging markers or other measures. This review proposes a path that may be suitable for osteoarthritis and poses some logical next steps that will take us in this direction.

Cite this article as:

J. Hunter David, Losina Elena, Guermazi Ali, Burstein Deb, N. Lassere Marissa and Kraus Virginia, A Pathway and Approach to Biomarker Validation and Qualification for Osteoarthritis Clinical Trials, Current Drug Targets 2010; 11 (5) . https://dx.doi.org/10.2174/138945010791011947