Evidence map›Paper›PMID 32840322›Full record

ArticleInflammatory bowel diseases2020

Biomarkers of Crohn's Disease to Support the Development of New Therapeutic Interventions.

Amy C Porter, Jiri Aubrecht, Chandler Birch, Jonathan Braun, Carolyn Cuff, Suryasarathi Dasgupta, Jeremy D Gale, Robert Hinton, Steven C Hoffmann, Gerard Honig and 4 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Inflammatory bowel diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  3. Review
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  10. Deep learningWorld journal of gastroenterology · 2021
    Article
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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

14 authors.

Amy C PorterCritical Path Institute, AZ, USA.
Jiri AubrechtTakeda Pharmaceuticals, Cambridge, MA, USA.
Chandler BirchCritical Path Institute, AZ, USA.
Jonathan BraunCedars-Sinai Medical Center, Los Angeles, CA, USA.
Carolyn CuffAbbVie Bioresearch Center, Worcester, MA, USA.
Suryasarathi DasguptaTakeda Pharmaceuticals, Cambridge, MA, USA.
Jeremy D GalePfizer Worldwide, Research, Development and Medical, Cambridge, MA, USA.
Robert HintonThe David R Clare and Margaret C Clare Foundation, Morristown, NJ, USA.
Steven C HoffmannFNIH, North Bethesda, MD, USA.
Gerard HonigCrohn's & Colitis Foundation, New York, NY, USA.
Bryan LinggiRobarts Clinical Trials, San Diego, CA, USA.
Marco SchitoCritical Path Institute, AZ, USA.
Niels Vande CasteeleDepartment of Medicine, University of California San Diego, CA, USA.
John-Michael SauerCritical Path Institute, AZ, USA.

Funding

Howard Hughes Medical InstituteWellcome Trust
6 · The paper itself

Abstract

backgroundCurrently, 2 coprimary end points are used by health authorities to determine the effectiveness of therapeutic interventions in patients with Crohn's disease (CD): symptomatic remission (patient-reported outcome assessment) and endoscopic remission (ileocolonoscopy). However, there is lack of accepted biomarkers to facilitate regulatory decision-making in the development of novel therapeutics for the treatment of CD.

methodsWith support from the Helmsley Charitable Trust, Critical Path Institute formed the Crohn's Disease Biomarkers preconsortium (CDBpC) with members from the pharmaceutical industry, academia, and nonprofit organizations to evaluate the CD biomarker landscape. Biomarkers were evaluated based on biological relevance, availability of biomarker assays, and clinical validation data.

resultsThe CDBpC identified the most critical need as pharmacodynamic/response biomarkers to monitor disease activity in response to therapeutic intervention. Fecal calprotectin (FC) and serum C-reactive protein (CRP) were identified as biomarkers ready for the regulatory qualification process. A number of exploratory biomarkers and potential panels of these biomarkers was also identified for additional development. Given the different factors involved in CD and disease progression, a combination of biomarkers, including inflammatory, tissue injury, genetic, and microbiome-associated biomarkers, will likely have the most utility.

conclusionsThe primary focus of the Inflammatory Bowel Disease Regulatory Science Consortium will be development of exploratory biomarkers and the qualification of FC and CRP for IBD. The Inflammatory Bowel Disease Regulatory Science Consortium, focused on tools to support IBD drug development, will operate in the precompetitive space to share data, biological samples for biomarker testing, and assay information for novel biomarkers.

Indexed as

BiomarkersClinical Decision-MakingConsensusC-Reactive ProteinCrohn DiseaseDrug DiscoveryDrug MonitoringFecesHumansLeukocyte L1 Antigen ComplexReproducibility of ResultsSeverity of Illness IndexBiomarkersC-Reactive ProteinLeukocyte L1 Antigen Complexbiomarkerbiomarker qualificationCrohn’s diseaseinflammatory bowel diseaseregulatory scienceulcerative colitis

Identifiers

PMID32840322
PMCPMC7500523

What OpenQuestion holds

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Registered trials

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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.