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FDA/Arthritis Foundation osteoarthritis drug development workshop recap : assessment of long-term benefit |
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| Author: | Kim, Jason S.1; Borges, Silvana2; Clauw, Daniel J.3; |
| Organizations: |
1The Arthritis Foundation, 1355 Peachtree St NE, Suite 600, Atlanta, GA 30309, USA 2US Food and Drug Administration, Silver Spring, MD, USA 3University of Michigan, Ann Arbor, MI, USA
4University of Leeds, Leeds, UK
5Boston University School of Medicine, Boston, MA, USA 6University of Washington, Seattle, WA, USA 7University of Maryland School of Medicine, Baltimore, MD, USA 8Duke University School of Medicine, Durham, NC, USA 9Cleveland Clinic, Cleveland, OH, USA 10University of California San Francisco, San Francisco, CA, USA 11Tufts-New England Medical Center, Boston, MA, USA 12University of Oulu, Oulu, Finland 13SDG LLC, Cambridge, MA, USA |
| Format: | article |
| Version: | accepted version |
| Access: | open |
| Online Access: | PDF Full Text (PDF, 0.2 MB) |
| Persistent link: | http://urn.fi/urn:nbn:fi-fe2023030930826 |
| Language: | English |
| Published: |
Elsevier,
2022
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| Publish Date: | 2023-03-09 |
| Description: |
AbstractObjective: 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. see all
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| Series: |
Seminars in arthritis and rheumatism |
| ISSN: | 0049-0172 |
| ISSN-E: | 1532-866X |
| ISSN-L: | 0049-0172 |
| Volume: | 56 |
| Article number: | 152070 |
| DOI: | 10.1016/j.semarthrit.2022.152070 |
| OADOI: | https://oadoi.org/10.1016/j.semarthrit.2022.152070 |
| Type of Publication: |
A2 Review article in a scientific journal |
| Field of Science: |
3121 General medicine, internal medicine and other clinical medicine 1182 Biochemistry, cell and molecular biology 317 Pharmacy |
| Subjects: | |
| Copyright information: |
© 2022. This manuscript version is made available under the CC-BY-NC-ND 4.0 license https://creativecommons.org/licenses/by-nc-nd/4.0/ |
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https://creativecommons.org/licenses/by-nc-nd/4.0/ |