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Trials@Home: Center of Excellence – Remote Decentralised Clinical Trials

Descrizione del progetto

DE EN ES FR IT PL

Portare a casa pazienti e studi clinici

Il progetto Trials@Home sta lavorando a una prova pilota su scala europea per studi clinici decentralizzati remoti (RDCT) che cambierà il modo in cui vengono condotti gli studi clinici e ridurrà la presenza obbligatoria di pazienti in ospedale. Ciò incoraggerebbe migliori tassi di reclutamento e mantenimento e condurrebbe a risultati efficaci in terapie specifiche e complesse. Gli strumenti di analisi e un maggiore coinvolgimento dei pazienti nei loro ambienti familiari porteranno a raccomandazioni e standard per RDCT, un migliore accesso ai trattamenti e risultati più rapidi negli studi clinici. Trials@Home comprende un consorzio che trarrà vantaggio da nuovi paradigmi nella progettazione della sperimentazione attuale e dai progressi digitali per fornire prove della fattibilità delle applicazioni RDCT nell’UE.

Obiettivo

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.

Parole chiave

Programma(i)

Argomento(i)

Invito a presentare proposte

H2020-JTI-IMI2-2018-14-two-stage

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Meccanismo di finanziamento

RIA - Research and Innovation action

Coordinatore

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Contribution nette de l'UE
€ 4 877 807,50
Indirizzo
HEIDELBERGLAAN 100
3584 CX Utrecht
Paesi Bassi

Mostra sulla mappa
Regione
West-Nederland Utrecht Utrecht
Tipo di attività
Higher or Secondary Education Establishments
Collegamenti
Costo totale
€ 4 882 841,30

Partecipanti (33)

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Ultimo aggiornamento: 31 Luglio 2024

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Permalink: https://cordis.europa.eu/project/id/831458/it

European Union, 2024