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

Project description

DEENESFRITPL

Bringing patients and clinical trials home

The Trials@Home project is working on a Europe-wide pilot for remote decentralised clinical trials (RDCTs) that will change the way clinical trials are carried out and reduce the obligatory presence of patients at hospital. This would encourage better recruitment and retention rates, and drive effective results in specific and complex therapies. The analysis tools and closer patient involvement in their familiar surroundings will lead to recommendations and standards for RDCTs, better access to treatments, and faster results in clinical trials. Trials@Home comprises a consortium that will take advantage of new paradigms in current trial design and digital advancements to provide evidence of the feasibility of RDCT applications in the EU.

Objective

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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Topic(s)

Call for proposal

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

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Funding Scheme

RIA - Research and Innovation action

Coordinator

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Net EU contribution
€ 4 844 307,50
Address
Heidelberglaan 100
3584 CX Utrecht
Netherlands

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Region
West-Nederland Utrecht Utrecht
Activity type
Higher or Secondary Education Establishments
Links
Other funding
€ 0,00

Participants (32)

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EC signature date 7 August 2019
Last update: 13 June 2023

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

European Union, 2023