2026-04-14T03:37:03Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/119132025-10-24T08:48:23Zcom_2072_378070com_2072_378040com_2072_378071col_2072_378092col_2072_378097

Needs assessment for creation of a platform trial network in metabolic-dysfunction associated steatohepatitis Sena, Elena Tacke, Frank Di Prospero, Nicholas A. Jiménez Masip, Alba Anstee, Quentin M. Kjær, Mette S muñoz, sergio Rivera-Esteban, Jesús Martínez Gómez, María Genesca, Joan Pericas, Juan M 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 Trial network; Steatohepatitis; Metabolic-dysfunction Red de ensayos; Esteatohepatitis; Disfunción metabólica Xarxa d'assaigs; Esteatohepatitis; Disfunció metabòlica Background 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. 2025-10-24T08:48:22Z 2025-10-24T08:48:22Z 2025-10-24T08:48:22Z 2024-09-16T05:44:54Z 2024-09-16T05:44:54Z 2024-07-16 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion http://hdl.handle.net/11351/11913 Communications Medicine;4 https://doi.org/10.1038/s43856-024-00560-5 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess Springer Nature Scientia