FDA/Arthritis Foundation osteoarthritis drug development workshop recap: Assessment of long-term benefit.
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.
Kim, JS; Borges, S; Clauw, DJ; Conaghan, PG; Felson, DT; Fleming, TR; Glaser, R; Hart, E; Hochberg, M; Kim, Y; Kraus, VB; Lapteva, L; Li, X; Majumdar, S; McAlindon, TE; Mobasheri, A; Neogi, T; Roemer, FW; Rothwell, R; Shibuya, R; Siegel, J; Simon, LS; Spindler, KP; Nikolov, NP
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