Deliverables
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 challengesThis 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 packageThis 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 trialsThis 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 EUSWOT (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-makingAnalysis 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 ecosystemPresentation 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 panelEthical 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 pilotMap 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 patientsThis 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.
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
Author(s):
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
Published in:
Clinical Pharmacology & Therapeutics, Issue 112/2, 2022, Page(s) 344-352, ISSN 0009-9236
Publisher:
Nature Publishing Group
DOI:
10.1002/cpt.2628
Author(s):
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
Published in:
Clinical Pharmacology & Therapeutics, Issue 109/6, 2021, Page(s) 1517-1527, ISSN 0009-9236
Publisher:
Nature Publishing Group
DOI:
10.1002/cpt.2225
Author(s):
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
Published in:
BMJ Open, Issue 12:e063236, 2022, ISSN 2044-6055
Publisher:
BMJ Publishing Group
DOI:
10.1136/bmjopen-2022-063236
Author(s):
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
Published in:
International Journal of Medical and Health Sciences, Issue 15(9), 2021, Page(s) 293-299, ISSN 2277-4505
Publisher:
International Journal of Medical and Health Sciences
DOI:
10.5281/zenodo.8318767
Author(s):
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
Published in:
Drug Discovery Today, Issue 27:10, 2022, ISSN 1359-6446
Publisher:
Elsevier BV
DOI:
10.1016/j.drudis.2022.07.011
Author(s):
Joanne Coyle, Amy Rogers, Rachel Copland, Giorgia De Paoli, Thomas M. MacDonald & Isla S. Mackenzie on behalf of the Trials@Home Consortium
Published in:
Trials, Issue 23/614, 2022, ISSN 1745-6215
Publisher:
BioMed Central
DOI:
10.1186/s13063-022-06521-4
Author(s):
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
Published in:
Trials, Issue 17456215, 2022, ISSN 1745-6215
Publisher:
BioMed Central
DOI:
10.1186/s13063-022-06706-x
Author(s):
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
Published in:
Drug Discovery Today, Issue 103520, 2023, ISSN 1359-6446
Publisher:
Elsevier BV
DOI:
10.1016/j.drudis.2023.103520
Author(s):
Joanne Coyle, Amy Rogers, Rachel Copland, Giorgia De Paoli, Thomas M. MacDonald, Isla S. Mackenzie
Published in:
British Journal of Clinical Pharmacology, 2021, ISSN 0306-5251
Publisher:
Blackwell Publishing Inc.
DOI:
10.1111/bcp.15003
Author(s):
Amos J. de Jong, Yared Santa-Ana-Tellez, Mira G. P. Zuidgeest, Renske J. Grupstra, Fatemeh Jami, Anthonius de Boer, Helga Gardarsdottir
Published in:
British Journal of Clinical Pharmacology, 2023, Page(s) 1-11, ISSN 0306-5251
Publisher:
Blackwell Publishing Inc.
DOI:
10.1111/bcp.15850
Author(s):
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
Published in:
British Journal of Clinical Pharmacology, 2021, ISSN 0306-5251
Publisher:
Blackwell Publishing Inc.
DOI:
10.1111/bcp.15205
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