IMI Trials@Home

Yet another paper published by Trials@Home! You can read it via the link below or via the project website https://lnkd.in/ebzY9vmF Congratulations to Rachel Copland and the rest of the team!

Very proud of Amos de Jong who will defend his thesis “Bringing clinical trials home” on Monday 7 October 2024, 14.15 hours in the ‘Academiegebouw, Domplein 29, Utrecht. You are welcome to witness his defence which will be in English. Innovative trial approaches enabled by technological and other operational advancements allow for the conduct of clinical trial activities away from investigative sites and close to participants. In this thesis, Amos de Jong explores opportunities and challenges for decentralized clinical trials (DCT) from the perspective of European stakeholders, as well as assesses the current use of DCT approaches. The research was conducted as part of the IMI Trials@Home project, a large public private partnership, which aims to reshape clinical trial design, conduct and operations, by developing and piloting standards, recommendations, and tools for the definition and operationalisation of DCTs in Europe. Cogratulations Amos de Jong. Thanks to the co-supervisors Ton de Boer, Yared Santa Ana Téllez and Mira Zuidgeest.

Trials@Home _ Semi-Annual Meeting, May 2024   Last May some 40 of us met in Thessaloniki, Greece, for two days full of meetings … and fun!    As per usual, the semi-annual meeting is mostly working meetings, an opportunity to meet in person and get things done. The survey amongst participants (in person and online) showed that the RADIAL session and the layman working group session were the most appreciated. Although it must be said that the Pub Quiz (at 9am) was pretty hilarious too 😁   Thank you, Pfizer, for hosting us. 

𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐏𝐚𝐩𝐞𝐫𝐬 𝐄𝐱𝐩𝐥𝐚𝐢𝐧𝐞𝐝 – 𝐟𝐢𝐫𝐬𝐭 𝐩𝐚𝐩𝐞𝐫 𝐭𝐫𝐚𝐧𝐬𝐥𝐚𝐭𝐞𝐝! “𝐄𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞𝐬 𝐨𝐟 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐭𝐫𝐢𝐚𝐥𝐬 𝐢𝐧 𝐡𝐨𝐦𝐞𝐬 𝐚𝐧𝐝 𝐥𝐨𝐜𝐚𝐥 𝐬𝐞𝐭𝐭𝐢𝐧𝐠𝐬 𝐨𝐮𝐭𝐬𝐢𝐝𝐞 𝐨𝐟 𝐜𝐥𝐢𝐧𝐢𝐜𝐬 – 𝐚 𝐫𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐩𝐫𝐨𝐣𝐞𝐜𝐭 𝐮𝐬𝐢𝐧𝐠 𝐢𝐧𝐭𝐞𝐫𝐯𝐢𝐞𝐰𝐬” WP CODE has recently formed a working group to translate technical/scientific documents into plain language for the general public including patients. It’s intended for those interested in learning more about decentralised clinical trials (DCT) in a more accessible and easily digestible format. The aim of this group is to foster accessibility of the Trials@Home materials, to increase awareness and educational opportunities surrounding DCTs. The group has now finished the translation of the first paper “Learning from remote decentralised clinical trial experiences: A qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders” Download the translation here -> https://bit.ly/3Xz5vdz

𝟭𝟬𝟬 𝗽𝗮𝗿𝘁𝗶𝗰𝗶𝗽𝗮𝗻𝘁𝘀 𝗲𝗻𝗿𝗼𝗹𝗹𝗲𝗱 𝗶𝗻 𝗥𝗔𝗗𝗜𝗔𝗟! 🙌  This month we reached the end of the recruitment phase in the RADIAL study and have enrolled over 100 participants. RADIAL is a proof-of-concept study conducted as part of IMI Trials@Home, a project funded by the Innovative Medicines Initiative (IMI). The trial is designed to compare a completely decentralized (home-based) and a hybrid approach with a conventional approach (site-based), incorporating several decentralized elements. This study involves participants living with type II diabetes and aims to innovate and understand the opportunities and challenges associated with the decentralization of clinical trials.   Key aspects of this methodological study include eConsent, home nursing, technological innovations including a device, central lab processes (including patient-drawn blood samples), a comprehensive study app, a central pharmacy that ships medication directly to participants, telehealth, and remote recruitment. The decentralization of clinical trials has the potential benefit to allow participants to conduct parts of the trial from home and collect data that closely resembles real-world conditions. Decentralized clinical trials can be crucial for increasing patient accessibility and engagement, ultimately leading to more inclusive and efficient research. The Julius Clinical team is extremely proud to have played a key role to bring these study elements into patients' homes, as partner of the IMI Trials@Home consortium led by UMC Utrecht and Sanofi. Want to know more about the RADIAL study? Visit https://lnkd.in/e_7Q8fv7

In the light of International Clinical Trials Day (20 May) and the theme of this year being “Trialblazers among us” we like to focus on the purpose of Trails@Home once more as we are not only running a proof of concept study RADIAL (https://lnkd.in/e_7Q8fv7), but the project also focuses on putting patients at the centre, not only of the trial but in the whole process of trail creation from A to Z. Kim Hawkins, Global Head of Clinical Project Operations at Sanofi, and the Project Co-Lead of the Trials@Home consortium was recently invited for a Vital Health Podcast, with Duane Schulthess where she outlines how Trials@Home is applying novel new innovative approaches to DCTs in order to evaluate different operational models of DCTs in RADIAL, the project’s pan-European proof of concept study. As well, Kim Hawkins describes how one of the project’s core missions is placing patient choices and opinions at the centre of decision making and implementation. Listen to the podcast here: https://bit.ly/3WMxjL4 #ClinicalTrialsDay #CTD2024

Proudly presented RADIAL and Trials@Home at DARQA Thanks so much for the opportunity to guide you, together with Fatemeh Jami, through the innovatieve landscape of decentralized elements in Clinical Trials. #trials@home #darqa

DIA Europe 2024 is coming up and Trials@Home will be there! On Wednesday, 13 March 2024, 15:10 – 16:20 CET, Dimitrios Athanasiou MBA, our World Duchenne Organisation project partner, will be a panelist on “Clinical Trials with Decentralised Elements” (S0202, Track: Clinical Trials Development & Operations) Session Description: This session will discuss the evolving global landscape for decentralised clinical trials, to (1) impact of recent and ongoing DCT initiatives and activities by various stakeholders (2) evaluate where we are in fulfilling the promise of DCTs for each stakeholder (3) debate what still needs to be done to advance the use of decentralised elements. More info here: https://lnkd.in/gJ-XEptC

HEALTHINF 2024 – 21_23 February, Rome, Italy. HEALTHINF, the 17th International Conference on Health Informatics, is part of BIOSTEC, the 17th International Joint Conference on Biomedical Engineering Systems and Technologies. Registration to HEALTHINF allows free access to all other BIOSTEC conferences. Sten Hanke, WP2 lead, will present on the Trials@Home Technology Support System and Review Process we use for RADIAL. Info and registration here: https://lnkd.in/edqW-3SE

Next Speaker of EUCROF24 is announced as…… EUCROF is delighted to announce that Bart Lagerwaard from UMC Utrecht will be presenting the session "Do Decentralised Clinical Trials improve representativeness?" at EUCROF24. Bart said “Decentralised clinical trials (DCTs) move the trial activities to the patient’s home and have the potential to enhance the conduct of clinical trials in multiple ways, including increasing the accessibility to the trial for a wider population by eliminating geographical barriers, and at the same time offering the participants the comfort and convenience of performing the trial from their homes. Does this potential of DCTs improve the representativeness of the trial?” In this presentation Bart will share initial learnings from setting-up and conducting the RADIAL trial, a decentralised and hybrid proof-of-concept trial that aims to answer these (and many other) research questions on DCTs. The session will highlight the interconnections between operational trial innovations and considerations for representativeness of the trial. EUCROF24 will be taking place in Prague from the 19-20 February. Find out more and view the full programme here: https://lnkd.in/eQP39Kx3 Dr. Martine Dehlinger-Kremer, Benedikt Van Nieuwenhove, Dagmar Chase, Yvonne Rollinger, Darina Hrdlickova, Simon Lee, Martin Krauss, Christophe Golenvaux, Donato Bonifazi, Martin O'Kane EUCROF Member Associations include: ACRO CZ, AECIC, AFCROs, AICRO - Associazione Italiana CRO, ASCRO, BeCRO, the Belgian Association of CROs, Bundesverband Medizinischer Auftragsinstitute e.V. (BVMA), CCRA, HACRO - Hellenic Association of CROs, Lithuanian GCP&RA Association, SAKDER, SACROP, ACCSCR, ACRON #clinicalresearch #clinicaltrials #clinicaloperations #gcp #bigpharma #dct #eucrof24 EUCROF Headquarters