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. Show the project objective Hide the project objective 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 remote clinical trials Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.7. - Innovative Medicines Initiative 2 (IMI2) Topic(s) IMI2-2018-14-04 - Centre Of Excellence – Remote Decentralised Clinical Trials Call for proposal H2020-JTI-IMI2-2018-14-two-stage See other projects for this call 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 See on map Region West-Nederland Utrecht Utrecht Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 Participants (32) Sort alphabetically Sort by Net EU contribution Expand all Collapse all JULIUS CLINICAL RESEARCH BV Netherlands Net EU contribution € 6 647 124,62 Address Broederplein 41-43 3703 CD Zeist See on map Region West-Nederland Utrecht Utrecht Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 858 505,38 STICHTING LYGATURE Netherlands Net EU contribution € 181 227,50 Address Jaarbeursplein 6 3521 AL Utrecht See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region West-Nederland Utrecht Utrecht Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD Participation ended United Kingdom Net EU contribution € 5 164,94 Address Wellington square university offices OX1 2JD Oxford See on map Region South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 FH JOANNEUM GESELLSCHAFT MBH Austria Net EU contribution € 795 375,00 Address Alte poststrasse 149 8020 Graz See on map Region Südösterreich Steiermark Graz Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 MEDICAL RESEARCH NETWORK LIMITED United Kingdom Net EU contribution € 572 802,00 Address Talon house presley way MK8 0ES Milton keynes See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region South East (England) Berkshire, Buckinghamshire and Oxfordshire Milton Keynes Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 ECLINICALHEALTH LTD United Kingdom Net EU contribution € 1 170 000,00 Address Logie court tirling university innovation park upper floor wing c FK9 4NF Stirling See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Scotland Eastern Scotland Perth & Kinross and Stirling Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UNIVERSITY OF DUNDEE United Kingdom Net EU contribution € 1 445 598,44 Address Nethergate DD1 4HN Dundee See on map Region Scotland Eastern Scotland Angus and Dundee City Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 SYDDANSK UNIVERSITET Denmark Net EU contribution € 110 312,50 Address Campusvej 55 5230 Odense m See on map Region Danmark Syddanmark Fyn Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 FUNDACION PARA EL FOMENTO DE LA INVESTIGACION SANITARIA Y BIOMEDICA DE LA COMUNITAT VALENCIANA Spain Net EU contribution € 355 675,00 Address Calle micer masco 31 46010 Valencia See on map Region Este Comunitat Valenciana Valencia/València Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 ETHNIKO KENTRO EREVNAS KAI TECHNOLOGIKIS ANAPTYXIS Greece Net EU contribution € 403 750,00 Address Charilaou thermi road 6 km 57001 Thermi thessaloniki See on map Region Βόρεια Ελλάδα Κεντρική Μακεδονία Θεσσαλονίκη Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 VITAL TRANSFORMATION Belgium Net EU contribution € 508 755,00 Address Leopold iii laan 107 1970 Wezembeek oppem See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Vlaams Gewest Prov. Vlaams-Brabant Arr. Halle-Vilvoorde Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 STICHTING MLC FOUNDATION Netherlands Net EU contribution € 198 750,00 Address Jaarbeursplein 6 3521 AL Utrecht See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region West-Nederland Utrecht Utrecht Activity type Other Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 FEDERATION INTERNATIONALE DU DIABETE REGION EUROPE AISBL Belgium Net EU contribution € 198 547,50 Address Avenue du bourgemestre etienne demunter 5b 1090 Bruxelles / brussel See on map Region Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 STICHTING UNITED PARENT PROJECTS MUSCULAR DYSTROPHY Netherlands Net EU contribution € 530 275,00 Address Koninginnelaan 69 3905 GG Veenendaal See on map Region West-Nederland Utrecht Utrecht Activity type Other Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 DREEM France Net EU contribution € 260 000,00 Address 34 boulevard des italiens 75009 Paris See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Ile-de-France Ile-de-France Paris Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UNIVERSITEIT UTRECHT Netherlands Net EU contribution € 809 332,50 Address Heidelberglaan 8 3584 CS Utrecht See on map Region West-Nederland Utrecht Utrecht Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT France Net EU contribution € 0,00 Address Pierre brossolette 1 91380 Chilly mazarin See on map Region Ile-de-France Ile-de-France Essonne Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 4 700 000,00 ALLERGAN LIMITED United Kingdom Net EU contribution € 0,00 Address 1st floor marlow international the parkway Marlow See on map Region South East (England) Berkshire, Buckinghamshire and Oxfordshire Buckinghamshire CC Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 2 000 000,00 ASTRAZENECA AB Sweden Net EU contribution € 0,00 Address Vastra maelarhamnen 151 85 Sodertaelje See on map Region Östra Sverige Stockholm Stockholms län Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 1 006 500,00 BAYER AKTIENGESELLSCHAFT Germany Net EU contribution € 0,00 Address Kaiser-wilhelm-allee 1 51373 Leverkusen See on map Region Nordrhein-Westfalen Köln Leverkusen, Kreisfreie Stadt Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 1 850 000,00 BOEHRINGER INGELHEIM INTERNATIONALGMBH Germany Net EU contribution € 0,00 Address Binger strasse 55218 Ingelheim See on map Region Rheinland-Pfalz Rheinhessen-Pfalz Mainz-Bingen Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 300 000,00 LABCORP CLINICAL DEVELOPMENT Belgium Net EU contribution € 0,00 Address Avenue du bourget 50 1130 Bruxelles See on map Region Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 1 000 000,00 IQVIA RDS FRANCE France Net EU contribution € 0,00 Address 151-161 boulevard victor hugo 93400 Saint-ouen See on map Region Ile-de-France Ile-de-France Seine-Saint-Denis Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 800 000,00 JANSSEN PHARMACEUTICA NV Belgium Net EU contribution € 0,00 Address Turnhoutseweg 30 2340 Beerse See on map Region Vlaams Gewest Prov. Antwerpen Arr. Turnhout Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 2 240 000,00 MEDTRONIC INTERNATIONAL TRADING SARL Switzerland Net EU contribution € 0,00 Address Route du molliau 31 1131 Tolochenaz See on map Region Schweiz/Suisse/Svizzera Région lémanique Vaud Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 200 000,00 NOVARTIS PHARMA AG Switzerland Net EU contribution € 0,00 Address Lichtstrasse 35 4056 Basel See on map Region Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Stadt Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 1 350 000,00 PFIZER LIMITED United Kingdom Net EU contribution € 0,00 Address Ramsgate road CT13 9NJ Sandwich See on map Region South East (England) Kent East Kent Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 1 204 500,00 TAKEDA DEVELOPMENT CENTRE EUROPE LTD Participation ended United Kingdom Net EU contribution € 0,00 Address Aldwych 61 WC2B 4AE London See on map Region London Inner London — West Westminster Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 21 406,02 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Israel Net EU contribution € 0,00 Address 5 basel st 49131 Petach tivka See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 514 167,00 UCB BIOPHARMA Belgium Net EU contribution € 0,00 Address Allee de la recherche 60 1070 Bruxelles / brussel See on map Region Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 1 337 628,00 TAKEDA PHARMACEUTICALS INTERNATIONAL AG Switzerland Net EU contribution € 0,00 Address Thurgauerstrasse 130 8152 Glattpark See on map Region Schweiz/Suisse/Svizzera Zürich Zürich Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 278 593,98 MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN Germany Net EU contribution € 0,00 Address Frankfurter strasse 250 64293 Darmstadt See on map Region Hessen Darmstadt Darmstadt, Kreisfreie Stadt Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 450 000,00