Kim, JS, Borges, S, Clauw, DJ et al. (21 more authors) (2022) FDA/Arthritis Foundation osteoarthritis drug development workshop recap: Assessment of long-term benefit. Seminars in Arthritis and Rheumatism, 56. 152070. ISSN 0049-0172
Abstract
Objective
To summarize proceedings of a workshop convened to discuss the current state of science in the disease of osteoarthritis (OA), identify the knowledge gaps, and examine the developmental and regulatory challenges in bringing these products to market.
Design
Summary of the one-day workshop held virtually on June 22nd, 2021.
Results
Speakers selected by the Planning Committee presented data on the current approach to assessment of OA therapies, biomarkers in OA drug development, and the assessment of disease progression and long-term benefit.
Conclusions
Demonstrated by numerous failed clinical trials, OA is a challenging disease for which to develop therapeutics. The challenge is magnified by the slow time of onset of disease and the need for clinical trials of long duration and/or large sample size to demonstrate the effect of an intervention. The OA science community, including academia, pharmaceutical companies, regulatory agencies, and patient communities, must continue to develop and test better clinical endpoints that meaningfully reflect disease modification related to long-term patient benefit.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2022 Elsevier Inc. All rights reserved. This is an author produced version of an article published in Seminars in Arthritis and Rheumatism. Uploaded in accordance with the publisher's self-archiving policy. |
Keywords: | Biomarkers; Clinical benefit; Disease-modifying therapy; Drug development; Long-term benefit; Osteoarthritis; Regulatory approval; Structure-modifying therapy |
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: | 10 Aug 2022 14:42 |
Last Modified: | 14 Jul 2023 00:13 |
Status: | Published |
Publisher: | Elsevier |
Identification Number: | 10.1016/j.semarthrit.2022.152070 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:189843 |