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

Información del proyecto

Trials@Home

Identificador del acuerdo de subvención: 831458

DOI

10.3030/831458

Proyecto cerrado

Fecha de la firma de la CE 7 Agosto 2019

Fecha de inicio 1 Septiembre 2019

Fecha de finalización 30 Noviembre 2025

Financiado con arreglo a

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coste total

€ 37 977 348,50

Aportación de la UE

€ 19 036 997,50

Coordinado por

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Netherlands

CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.

Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .

Resultado final

Documents, reports (16)

Report on changing stakeholders' roles and responsibilities and proposals from stakeholders to overcome any challenges

This deliverable reports on the results of the surveys which aimed to identify the benefits and downsides of DCTs that several stakeholder groups perceive, as well as their current knowledge and familiarity with DCTs. The goal is to measure and quantify the paradigm change inherent in a move from traditional trial methodology towards DCTs.

First version of Data management plan (task 6.4)

The Data Management Plan (DMP) provides a description of the data management that will be applied in the Trials@Home project. Full DMP will be published at the end of the IMI Trials@Home project.

First study subject approvals package

This document describes the submission and approval of the pan-EU proof-of-concept study in the Clinical Trials Information System (CTIS) and in the United Kingdom.

Criteria for selection of appropriate trials

This document serves as a tool which can be used to help deciding which decentralised trial methodologies may or may not be appropriate for a particular trial or research question.

SWOT analysis of ethical, legal and operational barriers and enablers for RDCT in the EU

SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis of the key trial activities that differ from traditional procedures, identifying the main challenges and proposing possible solutions to solve them.

Detailed list of quality assessment criteria and assessment procedures (task 2.1.2)

This report describes the development of the quality criteria and assessment procedures for the quality assessment of the technologies for the pan-European proof-of-concept study.

Ethics D4, POPD - Requirement No. 4: Updated data management plan.

The Data Management Plan (DMP) provides a description of the data management that will be applied in the Trials@Home project. This updated version includes the DMP for the pan-EU proof-of-concept study. Full DMP will be published at the end of the IMI Trials@Home project.

Overview of technical and regulatory implications of RDCTs for efficient regulatory decision-making

Analysis of the language surrounding DCTs, the regulatory perspectives, and the complex interplay of technical and regulatory dimensions of DCTs in diverse clinical areas, in order to scrutinise the technical and regulatory nuances of DCTs to streamline regulatory decision-making processes.

Overview of innovative scenarios for a responsible and sustainable RDCT ecosystem

Presentation of scenarios based on the most important aims of DCTs and presents potential solutions and proposals for overcoming challenges.

Glossary of terms and definitions used within WP2 (task 2.1.1)

Glossary to establish a common language and to aid understanding of key terms that will feature in project outputs. The glossary itself, presented in the document, may be updated during the Trials@Home project so that important new terms can be added, obsolete terms removed, or existing terms updated to significant new insights.

Open call for additional technology partners (task 6.6)

This report describes the process of selecting additional technology/service providers for providing technologies to be deployed in the Trials@Home pan-EU proof-of-concept study.

First set of recommendations for RDCTs (to be implemented in the pan-EU pilot RDCT)

Draft recommendations for decentralised clinical trial methods. They apply to all aspects of DCTs from design, planning and set-up to close-out and reporting. Full recommendations will be published at the end of the IMI Trials@Home project.

Ethics D1a, GEN-Requirement: Independent Ethics Advisor appointed to participate in the independent external expert panel

Ethical guidance for the Trials@Home project is built into the project in several manners. This includes the appointment of an independent ethics edvisor, to monitor the ethics issues involved in this project and how they are handled.

Map of the EU legislation on RDCTs including legal, regulatory, ethical and stakeholder recommendations for conduct of the pan-EU pilot

Map and analysis of the regulatory, ethical, good clinical practice (GCP) and legal aspects of the current European Union (EU) environment relevant to DCTs.

Midterm recruitment report

Midterm recruitment report.

Report on the mapping of paradigm changes in the relationships between HCPs and patients

This report details how WP CODE met with stakeholders through virtual roundtables, then identified key stakeholder groups and developed targeted surveys to probe these groups as part of Task 5.3 (Stakeholder Market Research on Opinions on DCTs).

Other (2)

Technology support system (task 2.6)

This report describes the technology support system that provides technical support for all parties involved in the pan-EU proof-of-concept study.

An interconnected, fully tested technology platform that connects the technological solutions chosen for the technology package and supports the WP3 pan-EU Pilot (task 2.5)

This report describes the technology platform that connects the technological solutions chosen for the technology package of the pan-EU proof-of-concept study.

Websites, patent fillings, videos etc. (1)

Trials@Home website, templates, and social media tools

This deliverable is the establishment of Trials@Home branding ideation, web development/hosting, social media handles, communication tools/ppt templates, social media style guides, and content style guides.

Publicaciones

Peer reviewed articles (29)

Do people prefer to take part in a clinical trial from home or come to site? A discrete choice experiment in type 2 diabetes mellitus

Autores: Julia Kopanz, Bart Lagerwaard, Jorien Veldwijk, Julia K Mader, Dietrich Tews, Thomas T van Sloten, Diederick E Grobbee, Mira G P Zuidgeest
Publicado en: BMJ Open, Edición 15, 2025, Página(s) e107737, ISSN 2044-6055
Editor: BMJ Publishing Group
DOI: 10.1136/bmjopen-2025-107737

The Ethics of Decentralized Clinical Trials and Informed Consent: Taking Technologies’ Soft Impacts into Account

Autores: Tessa I. van Rijssel, Ghislaine J. M. W. van Thiel, Johannes J. M. van Delden, null null
Publicado en: Health Care Analysis, 2024, ISSN 1065-3058
Editor: Kluwer Academic Publishers
DOI: 10.1007/s10728-024-00483-1

Opportunities and Challenges for Decentralized Clinical Trials: European Regulators’ Perspective

Autores: Amos J. de Jong, Tessa I. van Rijssel, Mira G. P. Zuidgeest, Ghislaine J. M. W. van Thiel, Scott Askin, Jaime Fons-Martínez, Tim De Smedt, Anthonius de Boer, Yared Santa-Ana-Tellez, Helga Gardarsdottir, on behalf of the Trials@Home Consortium
Publicado en: Clinical Pharmacology & Therapeutics, Edición 112/2, 2022, Página(s) 344-352, ISSN 0009-9236
Editor: Nature Publishing Group
DOI: 10.1002/cpt.2628

Regulatory Interactions and Learnings— <scp>RADIAL</scp> the Trials@Home Proof‐of‐Concept Trial on Decentralization

Autores: Helga Gardarsdottir, Hamidou Traore, Kate Huntley, Dinesh Mistry, Amos J. de Jong, Agnes Legathe, Tim de Smedt, Scott Askin, Megan Heath, Solange Corriol‐Rohou, Bart Lagerwaard, Mira G.P. Zuidgeest,
Publicado en: Clinical Pharmacology &amp; Therapeutics, Edición 118, 2025, Página(s) 1046-1056, ISSN 0009-9236
Editor: Nature Publishing Group
DOI: 10.1002/cpt.70078

Diversity in decentralized clinical trials: prioritizing inclusion of underrepresented groups

Autores: Tessa I. van Rijssel, Johannes J. M. van Delden, Bart Lagerwaard, Mira G. P. Zuidgeest, Ghislaine J. M. W. van Thiel, null null
Publicado en: BMC Medical Ethics, Edición 26, 2025, Página(s) 51, ISSN 1472-6939
Editor: BioMed Central
DOI: 10.1186/s12910-025-01211-7

Bringing Trial Activities to Participants—The Trials@Home <scp>RADIAL</scp> Proof‐of‐Concept Trial Investigating Decentralization of Trials

Autores: Mira G.P. Zuidgeest, Megan Heath, Bart Lagerwaard, Danny R. van Weelij, Linda Rutgrink, Sten Hanke, Tea Vedenkannas, Taru Kosonen, Stefania Collamati, Jaime Fons‐Martínez, Duco Veen, Helga Gardarsd
Publicado en: Clinical Pharmacology &amp; Therapeutics, Edición 118, 2025, Página(s) 1037-1045, ISSN 0009-9236
Editor: Nature Publishing Group
DOI: 10.1002/cpt.70025

The impact of operational trial approaches on representativeness: Comparison of decentralized clinical trial participants, conventional trial participants, and patients in daily practice

Autores: Amos J. de Jong, Mira G.P. Zuidgeest, Yared Santa-Ana-Tellez, Christine E. Hallgreen, Thomas T. van Sloten, Anthonius de Boer, Helga Gardarsdottir
Publicado en: Drug Discovery Today, Edición 30, 2025, Página(s) 104304, ISSN 1359-6446
Editor: Elsevier BV
DOI: 10.1016/j.drudis.2025.104304

COVID‐19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union

Autores: Amos Jochanan Jong, Yared Santa‐Ana‐Tellez, Ghislaine José Madeleine Wilhelmien Thiel, Mira Gerta Petra Zuidgeest, Satu Johanna Siiskonen, Dinesh Mistry, Anthonius Boer, Helga Gardarsdottir
Publicado en: Clinical Pharmacology & Therapeutics, Edición 109/6, 2021, Página(s) 1517-1527, ISSN 0009-9236
Editor: Nature Publishing Group
DOI: 10.1002/cpt.2225

Which decentralised trial activities are reported in clinical trial protocols of drug trials initiated in 2019–2020? A cross-sectional study in ClinicalTrials.gov

Autores: Amos J de Jong, Renske J Grupstra, Yared Santa-Ana-Tellez, Mira G P Zuidgeest, Anthonius de Boer, Helga Gardarsdottir, On behalf of Trials@Home consortium
Publicado en: BMJ Open, Edición 12:e063236, 2022, ISSN 2044-6055
Editor: BMJ Publishing Group
DOI: 10.1136/bmjopen-2022-063236

An Overview of Technology Availability to Support Remote Decentralized Clinical Trials

Autores: S. Huber, B. Schnalzer, B. Alcalde, S. Hanke, L. Mpaltadoros, T. G. Stavropoulos, S. Nikolopoulos, I. Kompatsiaris, L. Pérez-Breva, V. Rodrigo-Casares, J. Fons-Martínez, J. de Bruin
Publicado en: International Journal of Medical and Health Sciences, Edición 15(9), 2021, Página(s) 293-299, ISSN 2277-4505
Editor: International Journal of Medical and Health Sciences
DOI: 10.5281/zenodo.8318767

Ethics review of decentralized clinical trials (DCTs): Results of a mock ethics review

Autores: Tessa I. van Rijssel, Amos J. de Jong, Yared Santa-Ana-Tellez, Martin Boeckhout, Mira G.P. Zuidgeest, Ghislaine J.M.W. van Thiel, on behalf of the Trials@Home Consortium
Publicado en: Drug Discovery Today, Edición 27:10, 2022, ISSN 1359-6446
Editor: Elsevier BV
DOI: 10.1016/j.drudis.2022.07.011

The Digital Platform and Its Emerging Role in Decentralized Clinical Trials

Autores: Rachel R Copland, Sten Hanke, Amy Rogers, Lampros Mpaltadoros, Ioulietta Lazarou, Alexandra Zeltsi, Spiros Nikolopoulos, Thomas M MacDonald, Isla S Mackenzie
Publicado en: Journal of Medical Internet Research, Edición 26, 2024, Página(s) e47882, ISSN 1438-8871
Editor: Journal of medical Internet Research
DOI: 10.2196/47882

A secondary qualitative analysis of stakeholder views about participant recruitment, retention, and adherence in decentralised clinical trials (DCTs)

Autores: Joanne Coyle, Amy Rogers, Rachel Copland, Giorgia De Paoli, Thomas M. MacDonald & Isla S. Mackenzie on behalf of the Trials@Home Consortium
Publicado en: Trials, Edición 23/614, 2022, ISSN 1745-6215
Editor: BioMed Central
DOI: 10.1186/s13063-022-06521-4

A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials

Autores: Arnela Suman, Jasmijn van Es, Helga Gardarsdottir, Diederick E. Grobbee, Kimberly Hawkins, Megan A. Heath, Isla S. Mackenzie, Ghislaine van Thiel, Mira G. P. Zuidgeest, on behalf of the Trials@ Home Consortium
Publicado en: Trials, Edición 17456215, 2022, ISSN 1745-6215
Editor: BioMed Central
DOI: 10.1186/s13063-022-06706-x

The Supply of Investigational Medicinal Product and Management of Study Materials for Decentralized Participants—Insights from the Trials@Home <scp>RADIAL</scp>

Autores: Megan Heath, Amos J. de Jong, Shaun Magorrian‐Spence, Chao Jin, Danny R. van Weelij, Lucas Pagnier, Yvonne van Rijswick, Volker Haufe, Bart Lagerwaard, Mira G. P. Zuidgeest, null null
Publicado en: Clinical Pharmacology &amp; Therapeutics, Edición 118, 2025, Página(s) 1079-1089, ISSN 0009-9236
Editor: Nature Publishing Group
DOI: 10.1002/cpt.70072

Diffused responsibilities in technology-driven health research: The case of artificial intelligence systems in decentralized clinical trials

Autores: Sam H.A. Muller, Tessa I. van Rijssel, Ghislaine J.M.W. van Thiel
Publicado en: Drug Discovery Today, Edición 30, 2025, Página(s) 104309, ISSN 1359-6446
Editor: Elsevier BV
DOI: 10.1016/j.drudis.2025.104309

Operationalizing Decentralized Clinical Trials: Technology Insights from the Trials@Home <scp>RADIAL</scp> Proof‐of‐Concept Trial

Autores: Sten Hanke, Dimitrios Giannikopoulos, Bernhard Neumayer, Tea Vedenkannas, Robert Davey, Lampros Mpaltadoros, Brian Guthrie, Rebecca Jackson, Bart Lagerwaard, Mira Zuidgeest, null null
Publicado en: Clinical Pharmacology &amp; Therapeutics, Edición 118, 2025, Página(s) 1090-1099, ISSN 0009-9236
Editor: Nature Publishing Group
DOI: 10.1002/cpt.70070

Selecting and Preparing Clinical Sites for the Successful Conduct of Decentralized Clinical Trial Activities–Findings From the Trials@Home <scp>RADIAL</scp> P

Autores: Katarzyna Lipinska, Danny van Weelij, Bart Lagerwaard, Linda Rutgrink, Eduard Vardianu, Petra Naster, Lina Pérez‐Breva, Paul Bodfish, Megan Heath, Yvonne van Rijswick, Diederick E. Grobbee, Mira G.
Publicado en: Clinical Pharmacology &amp; Therapeutics, Edición 118, 2025, Página(s) 1057-1066, ISSN 0009-9236
Editor: Nature Publishing Group
DOI: 10.1002/cpt.70075

Decentralised, patient-centric, site-less, virtual, and digital clinical trials? From confusion to consensus

Autores: Yared Santa-Ana-Tellez; Bart Lagerwaard; Amos J de Jong; Helga Gardarsdottir; Diederick E Grobbee; Kimberly Hawkins; Megan Heath; Mira GP Zuidgeest; Trials@Home consortium
Publicado en: Drug Discovery Today, Edición 103520, 2023, ISSN 1359-6446
Editor: Elsevier BV
DOI: 10.1016/j.drudis.2023.103520

What motivates people with type 2 diabetes mellitus to participate in clinical trials from home?

Autores: Julia Kopanz, Bart Lagerwaard, Magdalena Beran, Jorien Veldwijk, Julia K. Mader, Tina Pöttler, Dietrich Tews, Diederick E. Grobbee, Mira G. P. Zuidgeest, null null
Publicado en: Clinical and Translational Science, Edición 17, 2024, ISSN 1752-8054
Editor: Wiley-Blackwell
DOI: 10.1111/cts.70070

Recruiting and Consenting Decentralized Clinical Trial Participants—Learnings from the Trials@Home <scp>RADIAL</scp> Proof‐of‐Concept Trial

Autores: Bart Lagerwaard, Linda Rutgrink, Danny van Weelij, Katarzyna Lipinska, Tina Bornemann, Robert Davey, Jaime Fons‐Martinez, Sabine Dupont, Diederick E. Grobbee, Mira G. P. Zuidgeest, null null
Publicado en: Clinical Pharmacology &amp; Therapeutics, Edición 118, 2025, Página(s) 1067-1078, ISSN 0009-9236
Editor: Nature Publishing Group
DOI: 10.1002/cpt.70042

Which Benefits Can Justify Risks in Research? Response to Open Peer Commentaries

Autores: Tessa I. van Rijssel, Ghislaine J. M. W. van Thiel, Helga Gardarsdottir, Johannes J. M. van Delden
Publicado en: The American Journal of Bioethics, Edición 25, 2025, ISSN 1526-5161
Editor: MIT Press
DOI: 10.1080/15265161.2025.2554767

Learning from remote decentralised clinical trial experiences: A qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders

Autores: Joanne Coyle, Amy Rogers, Rachel Copland, Giorgia De Paoli, Thomas M. MacDonald, Isla S. Mackenzie
Publicado en: British Journal of Clinical Pharmacology, 2021, ISSN 0306-5251
Editor: Blackwell Publishing Inc.
DOI: 10.1111/bcp.15003

Direct-to-Participant Investigational Medicinal Product Supply in Europe – Experiences from Sponsors, Site Study Staff, and Couriers

Autores: Amos J. de Jong, Yared Santa-Ana-Tellez, Mira G. P. Zuidgeest, Renske J. Grupstra, Fatemeh Jami, Anthonius de Boer, Helga Gardarsdottir
Publicado en: British Journal of Clinical Pharmacology, 2023, Página(s) 1-11, ISSN 0306-5251
Editor: Blackwell Publishing Inc.
DOI: 10.1111/bcp.15850

Which Benefits Can Justify Risks in Research?

Autores: Tessa I. van Rijssel, Ghislaine J. M. W. van Thiel, Helga Gardarsdottir, Johannes J. M. van Delden, null null
Publicado en: The American Journal of Bioethics, 2024, Página(s) 1-11, ISSN 1526-5161
Editor: MIT Press
DOI: 10.1080/15265161.2023.2296404

Opportunities and Challenges for Decentralized Clinical Trial Approaches: European Health Technology Assessment Perspective

Autores: Amos J. de Jong, Nadi Shahid, Mira G.P. Zuidgeest, Yared Santa-Ana-Tellez, Milou Hogervorst, Wim Goettsch, Hamidou Traore, Anthonius de Boer, Helga Gardarsdottir
Publicado en: Value in Health, Edición 27, 2024, Página(s) 294-300, ISSN 1098-3015
Editor: Blackwell Publishing Inc.
DOI: 10.1016/j.jval.2023.11.006

A Systematic Review of Methods used to Conduct Decentralised Clinical Trials

Autores: Amy Rogers, Giorgia De Paoli, Selvarani Subbarayan, Rachel Copland, Kate Harwood, Joanne Coyle, Lyn Mitchell, Thomas M MacDonald, Isla S Mackenzie, on behalf of the Trials@Home Consortium
Publicado en: British Journal of Clinical Pharmacology, 2021, ISSN 0306-5251
Editor: Blackwell Publishing Inc.
DOI: 10.1111/bcp.15205

Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitus

Autores: Julia Kopanz, Amy Rogers, Lina Pérez‐Breva, Emily Hall, Prashasthi Devaiah, Isla S. Mackenzie, Bart Lagerwaard, Diederick E. Grobbee, Mira G. P. Zuidgeest, null null
Publicado en: British Journal of Clinical Pharmacology, 2025, ISSN 0306-5251
Editor: Blackwell Publishing Inc.
DOI: 10.1002/bcp.70258

Regulatory readiness to facilitate the appropriate use of innovation in clinical trials: The case of decentralized clinical trial approaches

Autores: Amos J. de Jong, Mira G.P. Zuidgeest, Yared Santa-Ana-Tellez, Anthonius de Boer, Helga Gardarsdottir
Publicado en: Drug Discovery Today, Edición 29, 2024, Página(s) 104180, ISSN 1359-6446
Editor: Elsevier BV
DOI: 10.1016/j.drudis.2024.104180

Thesis and dissertations (2)

Bringing clinical research to patients

Autores: null null, Tessa Ivonne van Rijssel
Publicado en: 2024, ISBN 978-94-6473-531-4
Editor: Utrecht University Library
DOI: 10.33540/2404

Bringing clinical trials home

Autores: null null, Amos Jochanan de Jong
Publicado en: 2024, ISBN 978-90-393-7701-7
Editor: Utrecht University Library
DOI: 10.33540/2431

Conference proceedings (1)

Technology Support System and Review Process for a Decentralized Clinical Trial: Trials@Home, RADIAL DCT as Case Study

Autores: Sten Hanke, Dimitrios Giannikopoulos, Hannes Hilberger, Theresa Weitlaner, Bernhard Neumayer
Publicado en: Proceedings of the 17th International Joint Conference on Biomedical Engineering Systems and Technologies, 2024, Página(s) 638-645
Editor: SCITEPRESS - Science and Technology Publications
DOI: 10.5220/0012433900003657