Biomarkers Consortium – PROGRESS OA: Clinical Evaluation and Qualification of Osteoarthritis Biomarkers


The Biomarkers Consortium’s PROGRESS OA – Clinical Evaluation and Qualification of Osteoarthritis Biomarkers Project is the second phase of a two-stage strategy to address the most fundamental obstacles to the development of new treatments for Osteoarthritis (OA). This project will validate the highest performing radiographic measures, MRI measures and biochemical markers from the Phase I OA Biomarkers Consortium Project, which was completed in 2015. The PROGRESS OA Project utilizes data from previously conducted clinical trials to determine the imaging and biochemical biomarkers that can be used as prognostic markers of disease progression at baseline and prognostic markers of disease progression that measure change over time. The results from this study will be used in a regulatory qualification submission package to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) to qualify the biomarkers for use in OA drug development.

The lack of tools for early diagnosis and measures to predict disease progression in OA continues to be a major hurdle in drug development, and there are currently no validated clinical biomarker endpoints for OA. The results of PROGRESS OA Project will provide a set of qualified biomarker tools that will impact clinical trial design by decreasing the number of patients needed, and decreasing the time and costs needed for OA drug development. The PROGRESS OA Project is a 3-year, $2.5 million project, which launched in 2018, scheduled to complete in 2021.


Public-Sector Partners

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Private-Sector Partners

  • Arthritis Foundation*
  • Biosplice Therapeutics, Inc*
  • Merck KGaA, Darmstadt, Germany*
  • Novartis*
  • Pfizer/Eli Lilly and Company*

Academic Partners

  • Duke University
  • University of Sydney

*Provided financial or in-kind support for this program.

FNIH Contacts


  • Qualify radiographic, MRI and biochemical biomarkers with the FDA as prognostic biomarkers of knee OA disease in order to stratify patients and allow for enrichment of clinical trials with identified OA progressors.

Results & Accomplishments


The FDA has accepted three PROGRESS OA LOIs. They can be found below:


  • Biomarkers in osteoarthritis: current status and outlook – the FNIH Biomarkers Consortium PROGRESS OA study. Hunter DJ, Collins JE, Deveza L, Hoffmann SC, Kraus VB. Skeletal Radiol. 2023 Jan 24. Read more


  • FNIH Web Announcement (August 2, 2018): FNIH Biomarkers Consortium Launches Project Seeking Regulatory Qualification of Biomarkers for Measuring Knee Osteoarthritis  Read more

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