Evidence map›Paper›PMID 37380011›Full record

ReviewOsteoarthritis and cartilage2023

Reflections from the OARSI 2022 clinical trials symposium: The pain of OA-Deconstruction of pain and patient-reported outcome measures for the benefit of patients and clinical trial design.

M A Karsdal, J Tambiah, D Felson, C Ladel, N P Nikolov, D Hodgins, A R Bihlet, T Neogi, C Baatenburg de Jong, A C Bay-Jensen and 4 more

Open access · bronzeAbstract readReview
In one paragraph

Review in Osteoarthritis and cartilage, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
5.9field-weighted citation impact, top 3% of its field
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

14 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Psychotropic Drug Use in Korean Patients With Osteoarthritis.Journal of Korean medical science · 2025
    Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
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

14 authors at 9 institutions in 9 countries.

M A KarsdalNordic Bioscience, Herlev, Denmark; Southern Danish University, Odense, Denmark. Electronic address: MK@nordicbio.com.
J TambiahBiosplice Therapeutics, San Diego, USA.
D FelsonBoston University School of Medicine, Boston, MA, USA.
C LadelCHL4special Consultancy, Darmstadt, Germany.
N P NikolovOffice of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
D HodginsDynamic Metrics Limited, Codicote, UK.
A R BihletNBCD A/S, Herlev, Denmark.
T NeogiBoston University School of Medicine, Boston, MA, USA.
C Baatenburg de JongDutch Arthritis Society, Amsterdam, the Netherlands.
A C Bay-JensenNordic Bioscience, Herlev, Denmark.
R BaronUniversity Medical Center Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.
A LaslopCommittee for Medicinal Products for Human Use (CHMP), European Medicines Agency, Amsterdam, the Netherlands; Bundesamt für Sicherheit im Gesundheitswesen (BASG), Vienna, Austria.
A MobasheriResearch Unit of Health Sciences and Technology, Faculty of Medicine, University of Oulu, Oulu, Finland; Department of Regenerative Medicine, State Research Institute Centre for Innovative Medicine, Vilnius, Lithuania; Department of Joint Surgery, First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China; World Health Organization Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Aging, Université de Liège, Liege, Belgium.
V B KrausDuke Molecular Physiology Institute, Duke University School of Medicine, Durham, NC, USA.
Duke University · USEuropean Medicines Agency · NLHerlev Hospital · DKNordic Bioscience (Denmark) · DKReumaNederland · NLUnited States Food and Drug Administration · USUniversity Hospital Schleswig-Holstein · DEUniversity of Liège · BEUniversity of Southern Denmark · DK

Funding

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

Abstract

objectiveOsteoarthritis (OA) drug development is hampered by a number of challenges. One of the main challenges is the apparent discordance between pain and structure, which has had a significant impact on drug development programs and has led to hesitance among stakeholders. Since 2017, the Clinical Trials Symposium (CTS) has been hosted under the Osteoarthritis Research Society International (OARSI) leadership. OARSI and the CTS steering committee yearly invite and encourage discussions on selected special subject matter between regulators, drug developers, clinicians, clinical researchers, biomarker specialists, and basic scientists to progress drug development in the OA field.

methodThe main topic for the 2022 OARSI CTS was to elucidate the many facets of pain in OA and to enable a discussion between regulators (Food and Drug Administration (FDA) and the European Medicines Agency (EMA)) and drug developers to clarify outcomes and study designs for OA drug development.

resultsSigns or symptoms indicative of nociceptive pain occur in 50-70% of OA patients, neuropathic-like pain in 15-30% of patients, and nociplastic pain in 15-50% of patients. Weight-bearing knee pain is associated with bone marrow lesions and effusions. There are currently no simple objective functional tests whose improvements correlate with patient perceptions.

conclusionsThe CTS participants, in collaboration with the FDA and EMA, raised several suggestions that they consider key to future clinical trials in OA including the need for more precise differentiation of pain symptoms and mechanisms, and methods to reduce placebo responses in OA trials.

Indexed as

OsteoarthritisOsteoarthritis, KneeClinical Trials as TopicHumansKnee JointPainPatient Reported Outcome MeasuresTreatment OutcomeBiomarkersClinical trial designEMAFDA

Identifiers

PMID37380011
PMCPMC11184959
OpenAlexW4382051816

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.