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

Publication ,  Journal Article
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 ...
Published in: Semin Arthritis Rheum
October 2022

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.

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Published In

Semin Arthritis Rheum

DOI

EISSN

1532-866X

Publication Date

October 2022

Volume

56

Start / End Page

152070

Location

United States

Related Subject Headings

  • Osteoarthritis
  • Humans
  • Drug Development
  • Disease Progression
  • Biomarkers
  • Arthritis & Rheumatology
  • 3202 Clinical sciences
  • 1117 Public Health and Health Services
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
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Kim, J. S., Borges, S., Clauw, D. J., Conaghan, P. G., Felson, D. T., Fleming, T. R., … Nikolov, N. P. (2022). FDA/Arthritis Foundation osteoarthritis drug development workshop recap: Assessment of long-term benefit. Semin Arthritis Rheum, 56, 152070. https://doi.org/10.1016/j.semarthrit.2022.152070
Kim, Jason S., Silvana Borges, Daniel J. Clauw, Philip G. Conaghan, David T. Felson, Thomas R. Fleming, Rachel Glaser, et al. “FDA/Arthritis Foundation osteoarthritis drug development workshop recap: Assessment of long-term benefit.Semin Arthritis Rheum 56 (October 2022): 152070. https://doi.org/10.1016/j.semarthrit.2022.152070.
Kim JS, Borges S, Clauw DJ, Conaghan PG, Felson DT, Fleming TR, et al. FDA/Arthritis Foundation osteoarthritis drug development workshop recap: Assessment of long-term benefit. Semin Arthritis Rheum. 2022 Oct;56:152070.
Kim, Jason S., et al. “FDA/Arthritis Foundation osteoarthritis drug development workshop recap: Assessment of long-term benefit.Semin Arthritis Rheum, vol. 56, Oct. 2022, p. 152070. Pubmed, doi:10.1016/j.semarthrit.2022.152070.
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. FDA/Arthritis Foundation osteoarthritis drug development workshop recap: Assessment of long-term benefit. Semin Arthritis Rheum. 2022 Oct;56:152070.
Journal cover image

Published In

Semin Arthritis Rheum

DOI

EISSN

1532-866X

Publication Date

October 2022

Volume

56

Start / End Page

152070

Location

United States

Related Subject Headings

  • Osteoarthritis
  • Humans
  • Drug Development
  • Disease Progression
  • Biomarkers
  • Arthritis & Rheumatology
  • 3202 Clinical sciences
  • 1117 Public Health and Health Services
  • 1103 Clinical Sciences