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

Informations projet

Trials@Home

N° de convention de subvention: 831458

DOI

10.3030/831458

Date de signature de la CE 7 Août 2019

Date de début 1 Septembre 2019

Date de fin 30 Novembre 2025

Financé au titre de

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

Coût total

€ 37 977 348,50

Contribution de l’UE

€ 19 036 997,50

Coordonné par

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Netherlands

CORDIS fournit des liens vers les livrables publics et les publications des projets HORIZON.

Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .

Livrables

Documents, reports (17)

Finalised list of KPI's to be used to qualify and quantify the flow of activities in the pilot

This report describes the final list of KPIs to be used to qualify and quantify the flow of activities in the pan-EU proof-of-concept study.

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.

Publications

Peer reviewed articles (14)

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

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

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

Auteurs: 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
Publié dans: Clinical Pharmacology & Therapeutics, Numéro 112/2, 2022, Page(s) 344-352, ISSN 0009-9236
Éditeur: Nature Publishing Group
DOI: 10.1002/cpt.2628

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

Auteurs: 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
Publié dans: Clinical Pharmacology & Therapeutics, Numéro 109/6, 2021, Page(s) 1517-1527, ISSN 0009-9236
Éditeur: 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

Auteurs: 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
Publié dans: BMJ Open, Numéro 12:e063236, 2022, ISSN 2044-6055
Éditeur: BMJ Publishing Group
DOI: 10.1136/bmjopen-2022-063236

An Overview of Technology Availability to Support Remote Decentralized Clinical Trials

Auteurs: 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
Publié dans: International Journal of Medical and Health Sciences, Numéro 15(9), 2021, Page(s) 293-299, ISSN 2277-4505
Éditeur: 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

Auteurs: 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
Publié dans: Drug Discovery Today, Numéro 27:10, 2022, ISSN 1359-6446
Éditeur: Elsevier BV
DOI: 10.1016/j.drudis.2022.07.011

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

Auteurs: Joanne Coyle, Amy Rogers, Rachel Copland, Giorgia De Paoli, Thomas M. MacDonald & Isla S. Mackenzie on behalf of the Trials@Home Consortium
Publié dans: Trials, Numéro 23/614, 2022, ISSN 1745-6215
Éditeur: 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

Auteurs: 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
Publié dans: Trials, Numéro 17456215, 2022, ISSN 1745-6215
Éditeur: BioMed Central
DOI: 10.1186/s13063-022-06706-x

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

Auteurs: 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
Publié dans: Drug Discovery Today, Numéro 103520, 2023, ISSN 1359-6446
Éditeur: Elsevier BV
DOI: 10.1016/j.drudis.2023.103520

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

Auteurs: Joanne Coyle, Amy Rogers, Rachel Copland, Giorgia De Paoli, Thomas M. MacDonald, Isla S. Mackenzie
Publié dans: British Journal of Clinical Pharmacology, 2021, ISSN 0306-5251
Éditeur: 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

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

Which Benefits Can Justify Risks in Research?

Auteurs: Tessa I. van Rijssel, Ghislaine J. M. W. van Thiel, Helga Gardarsdottir, Johannes J. M. van Delden, null null
Publié dans: The American Journal of Bioethics, 2024, Page(s) 1-11, ISSN 1526-5161
Éditeur: MIT Press
DOI: 10.1080/15265161.2023.2296404

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

Auteurs: 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
Publié dans: Value in Health, Numéro 27, 2024, Page(s) 294-300, ISSN 1098-3015
Éditeur: Blackwell Publishing Inc.
DOI: 10.1016/j.jval.2023.11.006

A Systematic Review of Methods used to Conduct Decentralised Clinical Trials

Auteurs: 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
Publié dans: British Journal of Clinical Pharmacology, 2021, ISSN 0306-5251
Éditeur: Blackwell Publishing Inc.
DOI: 10.1111/bcp.15205

Conference proceedings (1)

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

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