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CORDIS

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

Leistungen

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.

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).

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.

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.

Veröffentlichungen

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

Autoren: 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
Veröffentlicht in: Clinical Pharmacology & Therapeutics, Ausgabe 112/2, 2022, Seite(n) 344-352, ISSN 0009-9236
Herausgeber: Nature Publishing Group
DOI: 10.1002/cpt.2628

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

Autoren: 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
Veröffentlicht in: Clinical Pharmacology & Therapeutics, Ausgabe 109/6, 2021, Seite(n) 1517-1527, ISSN 0009-9236
Herausgeber: 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

Autoren: 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
Veröffentlicht in: BMJ Open, Ausgabe 12:e063236, 2022, ISSN 2044-6055
Herausgeber: BMJ Publishing Group
DOI: 10.1136/bmjopen-2022-063236

An Overview of Technology Availability to Support Remote Decentralized Clinical Trials

Autoren: 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
Veröffentlicht in: International Journal of Medical and Health Sciences, Ausgabe 15(9), 2021, Seite(n) 293-299, ISSN 2277-4505
Herausgeber: 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

Autoren: 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
Veröffentlicht in: Drug Discovery Today, Ausgabe 27:10, 2022, ISSN 1359-6446
Herausgeber: 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)

Autoren: Joanne Coyle, Amy Rogers, Rachel Copland, Giorgia De Paoli, Thomas M. MacDonald & Isla S. Mackenzie on behalf of the Trials@Home Consortium
Veröffentlicht in: Trials, Ausgabe 23/614, 2022, ISSN 1745-6215
Herausgeber: 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

Autoren: 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
Veröffentlicht in: Trials, Ausgabe 17456215, 2022, ISSN 1745-6215
Herausgeber: BioMed Central
DOI: 10.1186/s13063-022-06706-x

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

Autoren: 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
Veröffentlicht in: Drug Discovery Today, Ausgabe 103520, 2023, ISSN 1359-6446
Herausgeber: 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

Autoren: Joanne Coyle, Amy Rogers, Rachel Copland, Giorgia De Paoli, Thomas M. MacDonald, Isla S. Mackenzie
Veröffentlicht in: British Journal of Clinical Pharmacology, 2021, ISSN 0306-5251
Herausgeber: 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

Autoren: Amos J. de Jong, Yared Santa-Ana-Tellez, Mira G. P. Zuidgeest, Renske J. Grupstra, Fatemeh Jami, Anthonius de Boer, Helga Gardarsdottir
Veröffentlicht in: British Journal of Clinical Pharmacology, 2023, Seite(n) 1-11, ISSN 0306-5251
Herausgeber: Blackwell Publishing Inc.
DOI: 10.1111/bcp.15850

A Systematic Review of Methods used to Conduct Decentralised Clinical Trials

Autoren: 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
Veröffentlicht in: British Journal of Clinical Pharmacology, 2021, ISSN 0306-5251
Herausgeber: Blackwell Publishing Inc.
DOI: 10.1111/bcp.15205

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