Evidence map›Paper›PMID 39014214›Full record

ArticleCommunications medicine2024

Needs assessment for creation of a platform trial network in metabolic-dysfunction associated steatohepatitis.

Elena Sena, Frank Tacke, Quentin M Anstee, Nicholas Di Prospero, Mette Skalshøi-Kjær, Sergio Muñoz-Martínez, Jesús Rivera-Esteban, Alba Jiménez-Masip, Jesús M Bañales, María Martínez-Gómez and 4 more

Abstract read
In one paragraph

Article in Communications medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Elena SenaLiver Unit, Vall d'Hebron University Hospital, Vall d'Hebron Institute for Research (VHIR), Universitat Autònoma de Barcelona, Spanish Network of Biomedical Research on Digestive and Liver Diseases (CIBERehd), Barcelona, Spain.ORCID http://orcid.org/0000-0003-1220-5639
Frank TackeDepartment of Hepatology and Gastroenterology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Quentin M AnsteeLiver Unit, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.ORCID http://orcid.org/0000-0002-9518-0088
Nicholas Di ProsperoJanssen Research and Development, Raritan, NJ, USA.
Mette Skalshøi-KjærNovo Nordisk A/S, Bagsvaerd, Denmark.
Sergio Muñoz-MartínezLiver Unit, Vall d'Hebron University Hospital, Vall d'Hebron Institute for Research (VHIR), Universitat Autònoma de Barcelona, Spanish Network of Biomedical Research on Digestive and Liver Diseases (CIBERehd), Barcelona, Spain.
Jesús Rivera-EstebanLiver Unit, Vall d'Hebron University Hospital, Vall d'Hebron Institute for Research (VHIR), Universitat Autònoma de Barcelona, Spanish Network of Biomedical Research on Digestive and Liver Diseases (CIBERehd), Barcelona, Spain.
Alba Jiménez-MasipLiver Unit, Vall d'Hebron University Hospital, Vall d'Hebron Institute for Research (VHIR), Universitat Autònoma de Barcelona, Spanish Network of Biomedical Research on Digestive and Liver Diseases (CIBERehd), Barcelona, Spain.
Jesús M BañalesDepartment of Liver and Gastrointestinal Diseases, Biodonostia Health Research Institute-Donostia University Hospital, University of the Basque Country (UPV/EHU), San Sebastian, Spanish Network of Biomedical Research on Digestive and Liver Diseases (CIBERehd), IKERBASQUE, Basque Foundation for Science, Bilbao, Spain.
María Martínez-GómezLiver Unit, Vall d'Hebron University Hospital, Vall d'Hebron Institute for Research (VHIR), Universitat Autònoma de Barcelona, Spanish Network of Biomedical Research on Digestive and Liver Diseases (CIBERehd), Barcelona, Spain.
Franz KoenigCenter for Medical Data Science, Medical University of Vienna, Vienna, Austria.
Joan GenescàLiver Unit, Vall d'Hebron University Hospital, Vall d'Hebron Institute for Research (VHIR), Universitat Autònoma de Barcelona, Spanish Network of Biomedical Research on Digestive and Liver Diseases (CIBERehd), Barcelona, Spain.ORCID http://orcid.org/0000-0002-0831-8422
Vlad RatziuDepartment of Hepatology, Pitié-Salpetriere Hospital, University Paris 6, Paris, France.
Juan M PericàsLiver Unit, Vall d'Hebron University Hospital, Vall d'Hebron Institute for Research (VHIR), Universitat Autònoma de Barcelona, Spanish Network of Biomedical Research on Digestive and Liver Diseases (CIBERehd), Barcelona, Spain. juanmanuel.pericas@vallhebron.cat.ORCID http://orcid.org/0000-0002-3645-3293

Funding

Innovative Medicines Initiative (IMI) grant agreement No 853966- 2.
6 · The paper itself

Abstract

backgroundThe EU Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) project (IMI2-853966) aimed to develop tools to establish integrated research platforms (IRP) for conducting adaptive-design trials in various diseases, including metabolic-dysfunction associated steatohepatitis (MASH). One essential component of a successful MASH IRP is a robust and reliable Clinical Research Network (CRN). Herein, we outline the required elements and anticipated steps to set-up such a CRN.

methodsWe identified European clinical research sites that could potentially serve as the foundation for MASH IRP and a CRN. A survey was sent to sites to assess their interest in joining a CRN, their familiarity with platform trials, and their capacity to participate in a future MASH IRP.

resultsA total of 141 investigators were invited to participate in the survey, and 40% responded. More than half of the answers (52%) identify MASH with advanced fibrosis (F3-4) as the subpopulation with the greatest unmet need. Regarding the difficulty in identifying candidates for trials, 65% find it is moderately difficult and 30% very difficult. Most respondents (94%) believe that a platform trial could offer substantial benefits to patients. Nearly all researchers express interest in participating in a platform trial (78%), with 22% indicating their interest would be contingent on initial industry funding.

conclusionWhile preliminary, our findings on responding sites are encouraging for the potential establishment of a CRN for a MASH IRP. However, funding schemes and sustainability strategies to provide proof-of-platform in MASH seem key in the short-term scenario.

Identifiers

PMID39014214
PMCPMC11253004

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.