Peer reviews & research outputs

All papers published as a result of the work done in the Trials@Home will be published here.

The Digital Platform and Its Emerging Role in Decentralized Clinical Trials

First published: 3 September 2024

Authors: Rachel R Copland; Sten Hanke; Amy Rogers; Lampros Mpaltadoros; Ioulietta Lazarou; Alexandra Zeltsi; Spiros Nikolopoulos; Thomas M MacDonald; Isla S Mackenzie

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

First published: 30 April 2024

Authors: Tessa I. van Rijssel · Ghislaine J. M. W. van Thiel ·
Johannes J. M. van Delden · On behalf of the Trials@Home consortium

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

First published: 21 February 2024

Authors: Sten Hanke, Dimitrios Giannikopoulos, Hannes Hilberger, Theresa Weitlaner and Bernhard Neumayer

Which Benefits Can Justify Risks in Research?

First published: 5 January 2024

Authors: Tessa I. van Rijssel, Ghislaine J. M. W. van Thiel, Helga Gardarsdottir, Johannes J. M. van Delden, on behalf of the Trials@Home consortium

Opportunities and challenges for decentralized clinical trial approaches: European health technology assessment perspective

First published: 1 December 2023

Authors: Amos J. de Jong, MSc, Nadi Shahid, BSc, Mira G.P. Zuidgeest, PhD, Yared Santa-Ana-Tellez, PhD, Milou Hogervorst, PharmD, Wim Goettsch, PhD, Hamidou Traore, PhD, Anthonius de Boer, PhD, Helga Gardarsdottir, PhD, on behalf of theTrials@Home Consortium

Direct-to-Participant Investigational Medicinal Product Supply in Clinical Trials in Europe – Exploring the Experiences of Sponsors, Site Staff, and Couriers

First published: 12 July 2023

Authors: Amos J. de Jong, Yared Santa-Ana-Tellez, Mira G. P. Zuidgeest, Renske J. Grupstra, Fatemeh Jami, Anthonius de Boer, Helga Gardarsdottir, on behalf of the Trials@Home Consortium

First published: 6 February 2023

Authors: Yared Santa-Ana-Tellez, Bart Lagerwaard, Amos J. de Jong, Helga Gardarsdottir, Diederick E. Grobbee, Kimberly Hawkins, Megan Heath, Mira G.P. Zuidgeest, on behalf of the Trials@Home Consortium

Green light for clinical research at patients’ homes?
Studies at patients’ homes may improve accessibility and inclusiveness of drug research

(white paper)

First published: 24 January 2023

Author: Amos J de Jong

Also available in Dutch: https://www.uu.nl/nieuws/studies-bij-patienten-thuis-maken-geneesmiddelenonderzoek-mogelijk-toegankelijker-en-inclusiever

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

First published: 6 February 2023

Authors: Yared Santa-Ana-Tellez, Bart Lagerwaard, Amos J. de Jong,
Helga Gardarsdottir, Diederick E. Grobbee, Kimberly Hawkins, Megan Heath, Mira G.P. Zuidgeest, on behalf of the Trials@Home Consortium

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

First published: 11 October 2022

Authors: 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 and on behalf of the Trials@Home Consortium

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

First published: 29 August 2022

Authors: 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

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

First published: 30 July 2022

Authors: Joanne Coyle, Amy Rogers, Rachel Copland, Giorgia De Paoli, Thomas M. MacDonald & Isla S. Mackenzie on behalf of the Trials@Home Consortium

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

First published: 20 July 2022

Authors: Tessa I.van Rijssel, Amos J.de Jong, YaredSanta-Ana-Tellez, Martin Boeckhout, Mira G.P.Zuidgeest, Ghislaine J.M.W.van Thiel, on behalf of theTrials@Home Consortium

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

First published: 30 April 2022

Authors: 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, The Trials@Home Consortium

A Systematic Review of Methods used to Conduct Decentralised Clinical Trials

First published: 27 December 2021

Authors: 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

An Overview of Technology Availability to Support Remote Decentralized Clinical Trials

First published: 28 September 2021

Authors: Huber, Simone; Schnalzer, Bianca; Alcalde, Baptiste; Hanke, Sten; Mpaltadoros, Lampros; Stavropoulos, Thanos; Nikolopoulos, Spiros; Kompatsiaris, Ioannis ; Pérez- Breva, Lina ; Rodrigo-Casares, Vallivana; Fons-Martínez, Jaime; De Bruin, Jeroen

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

First published: 13 July 2021

Authors: Joanne Coyle, Amy Rogers, Rachel Copland, Giorgia De Paoli, Thomas M. MacDonald, Isla S. Mackenzie, on behalf of the Trials@HomeConsortium

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

First published: 05 March 2021

Authors: Amos Jochanan de Jong, Yared Santa‐Ana‐Tellez, Ghislaine José Madeleine Wilhelmien van Thiel, Mira Gerta Petra Zuidgeest, Satu Johanna Siiskonen, Dinesh Mistry, Anthonius de Boer, Helga Gardarsdottir. On behalf of the Trials@Home Consortium