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Trials@Home

Financiado

Cerrado

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... ver más

30/11/2025

UMC UTRECHT

38M€

Presupuesto del proyecto: 38M€

Líder del proyecto

UNIVERSITAIR MEDISCH CENTRUM UTRECHT No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Ver 34 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2019-08-07

IMI2-2018-14-04: Centre Of Excellence – Remote Decen...

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Cerrada hace 6 años

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Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

34 Participantes

UMC UTRECHT

4.88M€ | Lider

COVEX RS EXTRUSION

323.95K€ | Participante

Allergan

N.D. | Participante

eClincalHealth

1.31M€ | Participante

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Duración del proyecto: 75 meses Fecha Inicio: 2019-08-07
Fecha Fin: 2025-11-30

Líder del proyecto

UNIVERSITAIR MEDISCH CENTRUM UTRECHT No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 38M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto 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.

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