Evidence map›Paper›PMID 25952342›Full record

ReviewOsteoarthritis and cartilage2015

OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis.

V B Kraus, F J Blanco, M Englund, Y Henrotin, L S Lohmander, E Losina, P Önnerfjord, S Persiani

Registry-linked trialAbstract readReview
In one paragraph

Review in Osteoarthritis and cartilage, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02964624 (Response of Osteoarthritis Biomarkers After a Rehabilitation Program), which is not on this map. Cited by 54 papers.

0numbers the graph read from it
0cells of the map it votes in
54citing 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.

NCT02964624 nacompletednot on this mapstarted 2018, after this paper: background citation

Response of Osteoarthritis Biomarkers After a Rehabilitation Program

TypeinterventionalSponsorHospital Israelita Albert EinsteinRan2018 to 2019Enrolled65ConditionsOsteoarthritisArmsRehabilitation
3 · Its place in the literature

Who cites it

54 citing papers in PubMed.

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  13. Logistic regression and other statistical tools in diagnostic biomarker studies.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
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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

8 authors.

V B KrausDuke Molecular Physiology Institute and Division of Rheumatology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA. Electronic address: vbk@duke.edu.
F J BlancoGrupo de Proteomica, ProteoRed/ISCIII, Servicio de Reumatologia, Instituto de Investigación Biomedica de A Coruña (INIBIC), Complexo Hospitalario Universitario de A Coruña (CHUAC), Sergas, Universidade da Coruña (UDC), As Xubias, 15006 A Coruña, Spain.
M EnglundOrthopedics, Clinical Sciences Lund, Lund University, Lund, Sweden; Clinical Epidemiology Research and Training Unit, Boston University School of Medicine, Boston University, MA, USA.
Y HenrotinBone and Cartilage Research Unit, Arthropôle Liège, University of Liège, CHU Sart-Tilman, 4000 Liège, Belgium; Department of Physical Therapy and Rehabilitation, Princess Paola Hospital, Marche-en-Famenne, Belgium.
L S LohmanderDepartment of Orthopedics, Clinical Sciences Lund, Lund University, Lund, Sweden; Research Unit for Musculoskeletal Function and Physiotherapy, and Department of Orthopedics and Traumatology, University of Southern Denmark, Odense, Denmark.
E LosinaOrthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, USA.
P ÖnnerfjordMolecular Skeletal Biology, Department of Clinical Sciences Lund, Lund University, Sweden.
S PersianiDepartment of Translational Sciences and Pharmacokinetics, Rottapharm Biotech, Monza, Italy.

Funding

Resource Core 3 - Metabolomics CoreP30AG028716 · NIA · DUKE UNIVERSITY · PI Virginia B Kraus · 2006 to 2026
$24.6M
Thermally-Triggered Intra-articular Drug Delivery for OAP01AR050245 · NIAMS · DUKE UNIVERSITY · PI KRAUS, VIRGINIA · 2003 to 2012
$11.5M
Patient Oriented Research and Mentoring Program in OrthopedicsK24AR057827 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI LOSINA, ELENA · 2010 to 2019
$1.7M
NIAMS NIH HHS K24 AR057827NIAMS NIH HHS P01 AR050245NIA NIH HHS P30 AG028716
6 · The paper itself

Abstract

The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety of reasons but in particular, to determine whether biomarkers are useful in identifying those individuals most likely to receive clinically important benefits from an intervention; and to determine whether biomarkers are useful for identifying individuals at earlier stages of OA in order to institute treatment at a time more amenable to disease modification.

Indexed as

BiomarkersClinical Trials as TopicHumansOsteoarthritisPractice Guidelines as TopicBiomarkersBiomarkersClinical trialsGuidelinesOsteoarthritis

Identifiers

PMID25952342
PMCPMC4430113

What OpenQuestion holds

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Read underepoch 390

Registered trials

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.