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Trials@Home

Financiado
Trials@Home Center of Excellence Remote Decentralised Clinical Trials
Clinical trials increase in size, complexity and costs. This is fuelled with the need to demonstrate effects in more complex therapeutic areas, and to detect subgroups with different benefit and safety responses. Complexities, rig... Clinical trials increase in size, complexity and costs. This is fuelled with the need to demonstrate effects in more complex therapeutic areas, and to detect subgroups with different benefit and safety responses. Complexities, rigid clinical control, physical distance and (perceived) burden put patient engagement under pressure. (S)low recruitment and retention compromise efficiency, generalisability and validity of traditional, site-centred trials. Remote Decentralized Clinical Trials (RDCTs) and hybrid approaches address these challenges. RDCTs are an operational strategy for technology-enhanced clinical trials, which enable (semi-)continuous data collection and real-world evidence generation, increase patient recruitment and retention and decrease patient and investigator burden and costs. Trials brought to the home of patients. Paradigmatic changes in EU clinical trial design are required to fully benefit from the digital era. Yet, the feasibility of running RDCTs needs to be rigorously demonstrated together with guidance and support measures for their execution. Trials@Home brings together a very strong consortium and will reshape clinical trial design, conduct and operations, by analysing, developing and piloting standards, recommendations and tools to define and operationalize RDCTs. Trials@Home will design and run a pan-European RDCT pilot based on: a. best practices of trials with RDCT elements, b. assessment of latest technological tools, c. the regulatory and ethical framework and potential changes required to facilitate RDCTs and d. stakeholder perspectives on the change from classical RCTs to RDCTs with strong patient involvement. The results of these assessments and the pilot will drive the formulation and dissemination of recommendations and tools for the implementation of RDCTs in Europe with the ultimate goal to improve the speed, quality and efficiency of clinical trials, and improving patients’ access to innovative treatment strategies. ver más
30/11/2025
UMC UTRECHT
38M€
Duración del proyecto: 75 meses Fecha Inicio: 2019-08-07
Fecha Fin: 2025-11-30

Línea de financiación: concedida

El organismo H2020 notifico la concesión del proyecto el día 2019-08-07
Línea de financiación objetivo El proyecto se financió a través de la siguiente ayuda:
IMI2-2018-14-04: Centre Of Excellence – Remote Decentralised Clinical Trials
Cerrada hace 6 años
Presupuesto El presupuesto total del proyecto asciende a 38M€
Líder del proyecto
UNIVERSITAIR MEDISCH CENTRUM UTRECHT No se ha especificado una descripción o un objeto social para esta compañía.
Perfil tecnológico TRL 4-5