2026-04-17T17:27:29Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/119132025-10-24T08:48:23Zcom_2072_378070com_2072_378040com_2072_378071col_2072_378092col_2072_378097
RECERCAT
author
Sena, Elena
author
Tacke, Frank
author
Di Prospero, Nicholas A.
author
Jiménez Masip, Alba
author
Anstee, Quentin M.
author
Kjær, Mette S
author
muñoz, sergio
author
Rivera-Esteban, Jesús
author
Martínez Gómez, María
author
Genesca, Joan
author
Pericas, Juan M
2025-10-24T08:48:22Z
2025-10-24T08:48:22Z
2024-09-16T05:44:54Z2024-09-16T05:44:54Z2024-07-16
http://hdl.handle.net/11351/11913
Trial network; Steatohepatitis; Metabolic-dysfunctionRed de ensayos; Esteatohepatitis; Disfunción metabólicaXarxa d'assaigs; Esteatohepatitis; Disfunció metabòlicaBackground
The 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.
Methods
We 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.
Results
A 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.
Conclusion
While 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.
Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess
Assaigs clínics
Metabolisme - Trastorns
Esteatosi hepàtica
DISEASES::Nutritional and Metabolic Diseases::Metabolic Diseases
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics::Clinical Studies as Topic::Clinical Trials as Topic
DISEASES::Digestive System Diseases::Liver Diseases::Fatty Liver::Non-alcoholic Fatty Liver Disease
ENFERMEDADES::enfermedades nutricionales y metabólicas::enfermedades metabólicas
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::métodos epidemiológicos::características de los estudios epidemiológicos::estudios clínicos como asunto::ensayos clínicos como asunto
ENFERMEDADES::enfermedades del sistema digestivo::enfermedades hepáticas::hígado graso::esteatosis hepática no alcohólica
Needs assessment for creation of a platform trial network in metabolic-dysfunction associated steatohepatitis
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion