M.A. Karsdal, J. Tambiah, M.C. Hochberg, C. Ladel, A.C. Bay-Jensen, L. Arendt-Nielsen, A. Mobasheri, V.B. Kraus, Reflections from the 2021 OARSI clinical trial symposium: Considerations for understanding biomarker assessments in osteoarthritis drug development - Should future studies focus on disease activity, rather than status?, Osteoarthritis and Cartilage Open, Volume 4, Issue 3, 2022, 100262, ISSN 2665-9131, https://doi.org/10.1016/j.ocarto.2022.100262
Reflections from the 2021 OARSI clinical trial symposium : considerations for understanding biomarker assessments in osteoarthritis drug development — should future studies focus on disease activity, rather than status?
|Author:||Karsdal, M. A.1,2; Tambiah, J.3; Hochberg, M. C.4;|
1Nordic Bioscience, Herlev, Denmark
2Southern Danish University, Odense, Denmark
3Biosplice Therapeutics, San Diego, USA
4University of Maryland School of Medicine, Baltimore, MD, USA
5Independent Consultant, Darmstadt, Germany
6Center for Neuroplasticity and Pain (CNAP), SMI, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark
7Research Unit of Medical Imaging, Physics and Technology, Faculty of Medicine, University of Oulu, Oulu, Finland
8Department of Regenerative Medicine, State Research Institute Centre for Innovative Medicine, Vilnius, Lithuania
9World Health Organization Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Aging, Liege, Belgium
10Duke Molecular Physiology Institute, Duke University School of Medicine, Durham, NC, USA
|Online Access:||PDF Full Text (PDF, 0.4 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe2023071190518
|Publish Date:|| 2023-07-11
Objective: Osteoarthritis (OA) is heterogeneous disease, for which drug development has proven to be challenging, both facilitated and hampered by changing guidelines. This is evident by the current lack of approved treatments, which improve joint function and delay joint failure. There is a need to bring together key stakeholders to discuss, align and enhance the processes for OA drug development to benefit patients.
Design: To facilitate drug development, the Osteoarthritis Research Society International (OARSI) initiated a series of annual clinical trials symposia (CTS). The aim of these symposia was to bring together academics, translational and clinical scientists, regulators, drug developers, and patient advocacy groups to share, refine and enhance the drug development process for the benefit of patients.
Results: OARSI is now considered the leading organization to facilitate open dialogue between all these stakeholders, in the intersection of understanding of the pathologies and drug development. Clearly, such a pivotal task needs an annual forum to allow stakeholders to share and discuss information, as possible solutions are joint efforts rather than a single stakeholder contribution.
Conclusions: The main topic of the 2021 CTS was how to improve clinical studies to help patients through overcoming barriers to development of new disease modifying treatments for OA. One key aspect was the focus on definitions of disease activity, status and the definitions of “illness vs disease”. There is a clear medical need to couple a given disease activity with the optimal intervention for the right patient.
Osteoarthritis and cartilage open
|Type of Publication:||
A1 Journal article – refereed
|Field of Science:||
3121 General medicine, internal medicine and other clinical medicine
Center for Neuroplasticity and Pain (CNAP) is supported by the Danish National Research Foundation (DNRF121).
© 2022 Published by Elsevier Ltd on behalf of Osteoarthritis Research Society International (OARSI). This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).