Evidence map›Paper›PMID 36130314›Full record

ArticleJournal of Crohn's & colitis2023

Paediatric Inflammatory Bowel Disease: A Multi-Stakeholder Perspective to Improve Development of Drugs for Children and Adolescents.

Nicholas M Croft, Lissy de Ridder, Anne M Griffiths, Jeffrey S Hyams, Frank M Ruemmele, Dan Turner, Katharine Cheng, Irja Lutsar, Marco Greco, Zuzanna Gołębiewska and 9 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of Crohn's & colitis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
12.6field-weighted citation impact, top 1% 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

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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

19 authors at 15 institutions in 9 countries.

Nicholas M CroftBlizard Institute, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK.ORCID 0000-0002-1519-6435
Lissy de RidderDepartment of Pediatric Gastroenterology, Erasmus MC Sophia Children's Hospital, Rotterdam, The Netherlands.
Anne M GriffithsInflammatory Bowel Disease Centre, The Hospital for Sick Children, University of Toronto, Canada.
Jeffrey S HyamsConnecticut Children's Medical Center, Hartford, CT, USA.
Frank M RuemmeleUniversité de Paris, Faculté de Médecine, Paris, France.
Dan TurnerShaare Zedek Medical Center, the Hebrew University of Jerusalem, Jerusalem, Israel.
Katharine ChengJohnson and Johnson, New Brunswick, Canada.
Irja LutsarInstitute of Medical Microbiology, University of Tartu, Tartu, Estonia.
Marco GrecoEuropean Patients' Forum (EPF), Chaussée d'Etterbeek, Brussels, Belgium.
Zuzanna GołębiewskaJ-elita, Polish Society for the Support of People with Inflammatory Bowel Disease, Warsaw, Poland.
Floriane LaumondAupetit François Association (AFA) Crohn RCH, Paris, France.
Maria Cavaller-BellaubiEURORDIS-Rare Diseases Europe, Paris, France.
Adam ElgreeyCrohn and Colitis Foundation Israel (CCFI), Tel Aviv, Israel.
Tara A AltepeterDivision of Gastroenterology, Office of Immunology and Inflammation, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Chrissi PallidisPaediatric Medicines, European Medicines Agency, The Netherlands.
Koen NorgaPaediatric Committee (PDCO), European Medicines Agency, The Netherlands.
Robert NelsonJohnson and Johnson, New Brunswick, Canada.
Wallace CrandallPediatric Immunology, Eli Lilly and Company, Indianapolis, IN, USA.
Gilles VassalDepartment of Pediatric and Adolescent Oncology, Gustave Roussy Comprehensive Cancer Center and Paris Saclay University, Villejuif, France.
European Medicines Agency · NLAssociation François Aupetit · FRConnecticut Children's Medical Center · USEli Lilly (United States) · USErasmus MC - Sophia Children’s Hospital · NLEuropean Federation of Allergy and Airways Diseases Patients Associations · BEEuropean Organisation for Rare Diseases · FRFoundation for Polish Science · PLHebrew University of Jerusalem · ILHôpital Necker-Enfants Malades · FRQueen Mary University of London · GBUnited States Food and Drug Administration · USUniversité Paris-Saclay · FRUniversity of Tartu · EEUniversity of Toronto · CA

Funding

European Federation of Pharmaceutical Industries and Associations
6 · The paper itself

Abstract

BACKGROUND AND

aimsDespite recent approvals for new drugs to treat adults with Crohn's disease or ulcerative colitis, there are only two approved advanced treatment options [infliximab and adalimumab] for children with inflammatory bowel disease [IBD]. There are many potential new therapies being developed for adult and paediatric IBD. Moreover, regulatory agencies in both the European Union and USA have processes in place to support the early planning and initiation of paediatric studies. Nevertheless, unacceptable delays in approvals for use of drugs in children persist, with an average 7-year gap, or longer, between authorization of new IBD drugs for adults and children.

methodsA 2-day virtual meeting was held during April 14-15, 2021 for multi-stakeholders [clinical academics, patient community, pharmaceutical companies and regulators] to discuss their perspectives on paediatric drug development for IBD.

resultsThe multi-stakeholder group presented, discussed and proposed actions to achieve expediting the approval of new drugs in development for paediatric IBD.

conclusionsCollaborative action points for all stakeholders are required to make progress and facilitate new drug development for children with IBD.

Indexed as

Colitis, UlcerativeCrohn DiseaseInflammatory Bowel DiseasesAdalimumabAdolescentAdultChildHumansInfliximabAdalimumabInfliximabdrug developmentMultipaediatric Crohn’s disease and ulcerative colitisstakeholder discussion

Identifiers

PMID36130314
PMCPMC10024546
OpenAlexW4297877805

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.