FDA/Arthritis Foundation osteoarthritis drug development workshop recap: Assessment of long-term benefit.

Autor: Kim JS; The Arthritis Foundation, 1355 Peachtree St NE, Suite 600, Atlanta, GA 30309, USA. Electronic address: jkim@arthritis.org., Borges S; US Food and Drug Administration, Silver Spring, MD, USA., Clauw DJ; University of Michigan, Ann Arbor, MI, USA., Conaghan PG; University of Leeds, Leeds, UK., Felson DT; Boston University School of Medicine, Boston, MA, USA., Fleming TR; University of Washington, Seattle, WA, USA., Glaser R; US Food and Drug Administration, Silver Spring, MD, USA., Hart E; US Food and Drug Administration, Silver Spring, MD, USA., Hochberg M; University of Maryland School of Medicine, Baltimore, MD, USA., Kim Y; US Food and Drug Administration, Silver Spring, MD, USA., Kraus VB; Duke University School of Medicine, Durham, NC, USA., Lapteva L; US Food and Drug Administration, Silver Spring, MD, USA., Li X; Cleveland Clinic, Cleveland, OH, USA., Majumdar S; University of California San Francisco, San Francisco, CA, USA., McAlindon TE; Tufts-New England Medical Center, Boston, MA, USA., Mobasheri A; University of Oulu, Oulu, Finland., Neogi T; Boston University School of Medicine, Boston, MA, USA., Roemer FW; Boston University School of Medicine, Boston, MA, USA., Rothwell R; US Food and Drug Administration, Silver Spring, MD, USA., Shibuya R; US Food and Drug Administration, Silver Spring, MD, USA., Siegel J; US Food and Drug Administration, Silver Spring, MD, USA., Simon LS; SDG LLC, Cambridge, MA, USA., Spindler KP; Cleveland Clinic, Cleveland, OH, USA., Nikolov NP; US Food and Drug Administration, Silver Spring, MD, USA.
Jazyk: angličtina
Zdroj: Seminars in arthritis and rheumatism [Semin Arthritis Rheum] 2022 Oct; Vol. 56, pp. 152070. Date of Electronic Publication: 2022 Jul 14.
DOI: 10.1016/j.semarthrit.2022.152070
Abstrakt: 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.
Competing Interests: Declaration of Competing Interest One or more of the authors has received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article.
(Copyright © 2022 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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