Designing an exploratory phase 2b platform trial in NASH with correlated, co-primary binary endpoints [dades primàries]

Meyer, Elias Laurin; Mesenbrink, Peter; Di Prospero, Nicholas A.; Pericàs Pulido, Juan Manuel; Glimm, Ekkehard; Ratziu, Vlad; De Sena Fernandez, Elena; König, Franz

dc.contributor	Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author	Meyer, Elias Laurin
dc.contributor.author	Mesenbrink, Peter
dc.contributor.author	Di Prospero, Nicholas A.
dc.contributor.author	Pericàs Pulido, Juan Manuel
dc.contributor.author	Glimm, Ekkehard
dc.contributor.author	Ratziu, Vlad
dc.contributor.author	De Sena Fernandez, Elena
dc.contributor.author	König, Franz
dc.date.accessioned	2023-03-23T12:58:17Z
dc.date.available	2023-03-23T12:58:17Z
dc.date.issued	2023-03-09
dc.identifier.citation	Meyer EL, Mesenbrink P, Di Prospero NA, Pericàs JM, Glimm E, Ratziu V, et al. Designing an exploratory phase 2b platform trial in NASH with correlated, co-primary binary endpoints [dades primàries]. 2023 Mar 9. PLoS One. Disponible a: https://doi.org/10.1371/journal.pone.0281674.s001
dc.identifier.uri	https://hdl.handle.net/11351/9229
dc.description	Dades simulades; Resultats
dc.description.abstract	Els assaigs de plataforma en NASH ofereixen grans beneficis per als patrocinadors i els participants pel que fa a l'acceleració dels programes de desenvolupament de medicaments. Es presenten els resultats d'un estudi de simulació. Inclou Taula S1 Dades simulades utilitzades per als resultats.
dc.description.sponsorship	EU-PEARL has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853966-2. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and CHILDREN’S TUMOR FOUNDATION, GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT NON PROFIT ORGANISATION, SPRINGWORKS THERAPEUTICS INC. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
dc.format.extent	73240 bytes
dc.format.mimetype	xlsx
dc.language.iso	eng
dc.publisher	Public Library of Science
dc.relation	Publicació relacionada: Meyer EL, Mesenbrink P, Di Prospero NA, Pericàs JM, Glimm E, Ratziu V, et al. Designing an exploratory phase 2b platform trial in NASH with correlated, co-primary binary endpoints. PLoS One. 2023 Mar 9;18(3):e0281674.
dc.relation.isreferencedby	https://scientiasalut.gencat.cat/handle/11351/9221
dc.rights	Attribution 4.0 International
dc.rights.uri	http://creativecommons.org/licenses/by/4.0/
dc.source	Scientia
dc.subject	Esteatosi hepàtica - Tractament
dc.subject	Medicina clínica - Investigació
dc.subject	Medicaments - Desenvolupament
dc.subject.mesh	Non-alcoholic Fatty Liver Disease
dc.subject.mesh	/drug therapy
dc.subject.mesh	Research Design
dc.title	Designing an exploratory phase 2b platform trial in NASH with correlated, co-primary binary endpoints [dades primàries]
dc.type	info:eu-repo/semantics/other
dc.identifier.doi	10.1371/journal.pone.0281674.s001
dc.subject.decs	esteatosis hepática no alcohólica
dc.subject.decs	/farmacoterapia
dc.subject.decs	diseño de la investigación
dc.type.subtype	Dades primaries
dc.type.version	info:eu-repo/semantics/publishedVersion
dc.audience	Professionals
dc.contributor.organismes	Institut Català de la Salut
dc.contributor.authoraffiliation	[Meyer EL, König F] Center for Medical Data Science, Medical University of Vienna, Vienna, Austria. [Mesenbrink P] Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, United States of America. [Di Prospero NA] Janssen Research and Development, Raritan, NJ, United States of America. [Pericàs JM] Servei d’Hepatologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Centros de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBERehd), ISCIII, Madrid, Spain. [Glimm E] Novartis Pharma AG, Basel, Switzerland. Institute of Biometry and Medical Informatics, University of Magdeburg, Magdeburg, Germany. [Ratziu V] Assistance Publique-Hôpitaux de Paris, Hôpital Pitie-Salpetriere, University of Paris, Paris, France. [Sena E] Servei d’Hepatologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain
dc.relation.projectid	info:eu-repo/grantAgreement/EC/H2020/853966-2
dc.rights.accessrights	info:eu-repo/semantics/openAccess