Project description
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.
Keywords
Programme(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
3584 CX Utrecht
Netherlands
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Participants (29)
3703 CD Zeist
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3521 AL Utrecht
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
8020 Graz
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MK8 0ES Milton Keynes
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
G2 5HS GLASGOW
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
CB25 9TU Cambridge
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
DD1 4HN Dundee
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5230 Odense M
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46010 Valencia
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57001 Thermi Thessaloniki
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1970 Wezembeek Oppem
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
1090 Bruxelles / Brussel
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3905 GG Veenendaal
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3584 CS Utrecht
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94250 GENTILLY
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151 85 Sodertaelje
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51373 Leverkusen
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55218 Ingelheim
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1130 Bruxelles / Brussel
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93400 Saint-Ouen
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2340 Beerse
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1131 Tolochenaz
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4056 Basel
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CT13 9NJ Sandwich
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49131 Petach Tivka
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1070 Bruxelles / Brussel
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8152 Glattpark
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64293 Darmstadt
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60064 North Chicago Il
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