Evidence map›Paper›PMID 21396468›Full record

ArticleOsteoarthritis and cartilage2011

Application of biomarkers in the development of drugs intended for the treatment of osteoarthritis.

V B Kraus, B Burnett, J Coindreau, S Cottrell, D Eyre, M Gendreau, J Gardiner, P Garnero, J Hardin, Y Henrotin and 11 more

Abstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in Osteoarthritis and cartilage, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 159 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
159citing papers in PubMed, 2 pooled it
–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

159 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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99 more citing papers are in PubMed but not listed here.

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

21 authors.

V B KrausDepartment of Medicine, Duke University Medical Center, Durham, NC 27710, USA. vbk@duke.edu
B Burnett
J Coindreau
S Cottrell
D Eyre
M Gendreau
J Gardiner
P Garnero
J Hardin
Y Henrotin
D Heinegård
A Ko
L S Lohmander
G Matthews
J Menetski
R Moskowitz
S Persiani
A R Poole
J-C Rousseau
M Todman
OARSI FDA Osteoarthritis Biomarkers Working Group

Funding

Pilot Project for the DTMI CRA ProgramUL1RR024128 · NCRR · DUKE UNIVERSITY · PI CALIFF, ROBERT M · 2006 to 2010
$48.1M
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 GUILAK, FARSHID · 2003 to 2012
$11.5M
NCRR NIH HHS 1 UL1 RR024128NCRR NIH HHS UL1 RR024128NIAMS NIH HHS AR50245NIAMS NIH HHS P01 AR050245NIA NIH HHS 5P30AG028716NIA NIH HHS P30 AG028716
6 · The paper itself

Abstract

objectiveOsteoarthritis (OA) is a chronic and slowly progressive disease for which biomarkers may be able to provide a more rapid indication of therapeutic responses to therapy than is currently available; this could accelerate and facilitate OA drug discovery and development programs. The goal of this document is to provide a summary and guide to the application of in vitro (biochemical and other soluble) biomarkers in the development of drugs for OA and to outline and stimulate a research agenda that will further this goal.

methodsThe Biomarkers Working Group representing experts in the field of OA biomarker research from both academia and industry developed this consensus document between 2007 and 2009 at the behest of the Osteoarthritis Research Society International Federal Drug Administration initiative (OARSI FDA initiative).

resultsThis document summarizes definitions and classification systems for biomarkers, the current outcome measures used in OA clinical trials, applications and potential utility of biomarkers for development of OA therapeutics, the current state of qualification of OA-related biomarkers, pathways for biomarker qualification, critical needs to advance the use of biomarkers for drug development, recommendations regarding practices and clinical trials, and a research agenda to advance the science of OA-related biomarkers.

conclusionsAlthough many OA-related biomarkers are currently available they exist in various states of qualification and validation. The biomarkers that are likely to have the earliest beneficial impact on clinical trials fall into two general categories, those that will allow targeting of subjects most likely to either respond and/or progress (prognostic value) within a reasonable and manageable time frame for a clinical study (for instance within 1-2 years for an OA trial), and those that provide early feedback for preclinical decision-making and for trial organizers that a drug is having the desired biochemical effect. As in vitro biomarkers are increasingly investigated in the context of specific drug treatments, advances in the field can be expected that will lead to rapid expansion of the list of available biomarkers with increasing understanding of the molecular processes that they represent.

Indexed as

BiomarkersClinical Trials as TopicDrug DiscoveryDrug MonitoringHumansOsteoarthritisSpecimen HandlingTreatment OutcomeBiomarkers

Identifiers

PMID21396468
PMCPMC3568396

What OpenQuestion holds

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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.