Evidence map›Paper›PMID 35870222›Full record

ReviewSeminars in arthritis and rheumatism2022

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

Jason S Kim, Silvana Borges, Daniel J Clauw, Philip G Conaghan, David T Felson, Thomas R Fleming, Rachel Glaser, Elizabeth Hart, Marc Hochberg, Yura Kim and 14 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Seminars in arthritis and rheumatism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Animal Models of Osteoarthritis: Updated Models and Outcome Measures 2016-2023.Regenerative engineering and translational medicine · 2024
    Article
  11. Review
  12. Article
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Jason S KimThe Arthritis Foundation, 1355 Peachtree St NE, Suite 600, Atlanta, GA 30309, USA. Electronic address: jkim@arthritis.org.
Silvana BorgesUS Food and Drug Administration, Silver Spring, MD, USA.
Daniel J ClauwUniversity of Michigan, Ann Arbor, MI, USA.
Philip G ConaghanUniversity of Leeds, Leeds, UK.
David T FelsonBoston University School of Medicine, Boston, MA, USA.
Thomas R FlemingUniversity of Washington, Seattle, WA, USA.
Rachel GlaserUS Food and Drug Administration, Silver Spring, MD, USA.
Elizabeth HartUS Food and Drug Administration, Silver Spring, MD, USA.
Marc HochbergUniversity of Maryland School of Medicine, Baltimore, MD, USA.
Yura KimUS Food and Drug Administration, Silver Spring, MD, USA.
Virginia B KrausDuke University School of Medicine, Durham, NC, USA.
Larissa LaptevaUS Food and Drug Administration, Silver Spring, MD, USA.
Xiaojuan LiCleveland Clinic, Cleveland, OH, USA.
Sharmila MajumdarUniversity of California San Francisco, San Francisco, CA, USA.
Timothy E McAlindonTufts-New England Medical Center, Boston, MA, USA.
Ali MobasheriUniversity of Oulu, Oulu, Finland.
Tuhina NeogiBoston University School of Medicine, Boston, MA, USA.
Frank W RoemerBoston University School of Medicine, Boston, MA, USA.
Rebecca RothwellUS Food and Drug Administration, Silver Spring, MD, USA.
Robert ShibuyaUS Food and Drug Administration, Silver Spring, MD, USA.
Jeffrey SiegelUS Food and Drug Administration, Silver Spring, MD, USA.
Lee S SimonSDG LLC, Cambridge, MA, USA.
Kurt P SpindlerCleveland Clinic, Cleveland, OH, USA.
Nikolay P NikolovUS Food and Drug Administration, Silver Spring, MD, USA.

Funding

Research and Evaluation Support Core Unit (RESCU Core)P30AR072571 · NIAMS · BOSTON UNIVERSITY MEDICAL CAMPUS · PI TUHINA NEOGI · 2019 to 2026
$6.9M
Intramural FDA HHS FD999999NIAMS NIH HHS P30 AR072571
6 · The paper itself

Abstract

objectiveTo 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.

designSummary of the one-day workshop held virtually on June 22nd, 2021.

resultsSpeakers 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.

conclusionsDemonstrated 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.

Indexed as

OsteoarthritisBiomarkersDisease ProgressionDrug DevelopmentHumansBiomarkersBiomarkersClinical benefitDisease-modifying therapyDrug developmentLong-term benefitOsteoarthritisRegulatory approvalStructure-modifying therapy

Identifiers

PMID35870222
PMCPMC9452453

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.