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
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 (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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 (se abrirá en una nueva ventana)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 (se abrirá en una nueva ventana)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 (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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. (se abrirá en una nueva ventana)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 (se abrirá en una nueva ventana)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 (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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) (se abrirá en una nueva ventana)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 (se abrirá en una nueva ventana)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 (se abrirá en una nueva ventana)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 (se abrirá en una nueva ventana)Midterm recruitment report.
Report on the mapping of paradigm changes in the relationships between HCPs and patients (se abrirá en una nueva ventana)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).
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) (se abrirá en una nueva ventana)This report describes the technology platform that connects the technological solutions chosen for the technology package of the pan-EU proof-of-concept study.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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