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Trials@Home SIGNED

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

Total Cost €

0

EC-Contrib. €

0

Partnership

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Project "Trials@Home" data sheet

The following table provides information about the project.

Coordinator
UNIVERSITAIR MEDISCH CENTRUM UTRECHT 

Organization address
address: HEIDELBERGLAAN 100
city: UTRECHT
postcode: 3584 CX
website: www.umcutrecht.nl

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Netherlands [NL]
 Total cost 38˙331˙269 €
 EC max contribution 19˙036˙997 € (50%)
 Programme 1. H2020-EU.3.1.7. (Innovative Medicines Initiative 2 (IMI2))
 Code Call H2020-JTI-IMI2-2018-14-two-stage
 Funding Scheme IMI2-RIA
 Starting year 2019
 Duration (year-month-day) from 2019-09-01   to  2024-08-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    UNIVERSITAIR MEDISCH CENTRUM UTRECHT NL (UTRECHT) coordinator 9˙023˙087.00
2    JULIUS CLINICAL RESEARCH BV NL (ZEIST) participant 2˙788˙815.00
3    UNIVERSITY OF DUNDEE UK (DUNDEE) participant 1˙313˙842.00
4    FH JOANNEUM GESELLSCHAFT MBH AT (GRAZ) participant 879˙625.00
5    UNIVERSITEIT UTRECHT NL (UTRECHT) participant 784˙505.00
6    MEDICAL RESEARCH NETWORK LIMITED UK (MILTON KEYNES) participant 709˙802.00
7    STICHTING UNITED PARENT PROJECTS MUSCULAR DYSTROPHY NL (VEENENDAAL) participant 594˙275.00
8    VITAL TRANSFORMATION BE (WEZEMBEEK OPPEM) participant 568˙755.00
9    ECLINICALHEALTH LTD UK (STIRLING) participant 513˙750.00
10    ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS EL (THERMI THESSALONIKI) participant 403˙750.00
11    FUNDACION PARA EL FOMENTO DE LA INVESTIGACION SANITARIA Y BIOMEDICA DE LA COMUNITAT VALENCIANA ES (VALENCIA) participant 400˙675.00
12    DREEM FR (PARIS) participant 260˙000.00
13    THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD UK (OXFORD) participant 250˙888.00
14    STICHTING MLC FOUNDATION NL (DEN HAAG) participant 198˙750.00
15    STICHTING LYGATURE NL (UTRECHT) participant 181˙227.00
16    SYDDANSK UNIVERSITET DK (ODENSE M) participant 110˙312.00
17    FEDERATION INTERNATIONALE DU DIABETE REGION EUROPE AISBL BE (BRUXELLES) participant 54˙937.00
18    ALLERGAN LIMITED UK (MARLOW) participant 0.00
19    ASTRAZENECA AB SE (SODERTAELJE) participant 0.00
20    BAYER AKTIENGESELLSCHAFT DE (Leverkusen) participant 0.00
21    BOEHRINGER INGELHEIM INTERNATIONALGMBH DE (INGELHEIM) participant 0.00
22    COVANCE CLINICAL AND PERIAPPROVAL SERVICES BE (WOLUWE-SAINT-LAMBERT) participant 0.00
23    IQVIA RDS FRANCE FR (SAINT-OUEN) participant 0.00
24    JANSSEN PHARMACEUTICA NV BE (BEERSE) participant 0.00
25    MEDTRONIC INTERNATIONAL TRADING SARL CH (TOLOCHENAZ) participant 0.00
26    NOVARTIS PHARMA AG CH (BASEL) participant 0.00
27    PFIZER LIMITED UK (SANDWICH) participant 0.00
28    SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT FR (Chilly Mazarin) participant 0.00
29    TAKEDA DEVELOPMENT CENTRE EUROPE LTD UK (LONDON) participant 0.00
30    TEVA PHARMACEUTICAL INDUSTRIES LIMITED IL (PETACH TIVKA) participant 0.00
31    UCB BIOPHARMA SRL BE (BRUXELLES) participant 0.00

Map

 Project 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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The information about "TRIALS@HOME" are provided by the European Opendata Portal: CORDIS opendata.

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