Katz, JN, Neogi, T, Callahan, LF et al. (5 more authors) (2020) Disease modification in osteoarthritis; pathways to drug approval. Osteoarthritis and Cartilage Open, 2 (2). 100059. ISSN 2665-9131
Abstract
Objective
To summarize proceedings of a workshop convened to discuss advances in disease modifying osteoarthritis (OA) drugs and regulatory challenges in bringing these drugs to market.
Design
Summary of a one day workshop held in Washington, DC in May 2019.
Results
Attendees presented data documenting the prevalence, cost and disability burden of OA; recent documentation of disease modification without concomitant clinical benefit in trials of disease modifying drugs; regulatory considerations pertinent to disease modifying therapy; and methodologic approaches to addressing these regulatory considerations.
Conclusions
The research, pharmaceutical and regulatory communities must continue to collaborate on defining pathways for approval of disease modifying osteoarthritis drugs that document effects on clinical endpoints (such as pain, function or joint replacement) as well as on bone, cartilage and other structures.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2020 The Authors. Published by Elsevier Ltd on behalf of Osteoarthritis Research Society International (OARSI). This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
Keywords: | Osteoarthritis; Structure-modifying therapy; Regulatory approval |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Institute of Rheumatology & Musculoskeletal Medicine (LIRMM) (Leeds) > Musculoskeletal Medicine & Imaging (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 09 Mar 2020 16:18 |
Last Modified: | 25 Jun 2023 22:11 |
Status: | Published |
Publisher: | Elsevier |
Identification Number: | 10.1016/j.ocarto.2020.100059 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:158159 |