IDF Europe is a consortium member of an EU-funded research project, Trials@Home, which aims to reshape clinical trial design, conduct and operations, by developing and piloting standards, recommendations and tools for the definition and operationalization of decentralized clinical trials (DCTs) in Europe.
Trials@Home’s third hybrid online-in person annual meeting took place in Wuppertal, Germany, on September 26 and 27.
During the annual meeting, work package leaders provided extensive updates on the progress achieved in the last year. Regarding communication, dissemination and outreach activities, Trials@Home was presented in various congresses and other events on more than 25 occasions and five new manuscripts were published. These can be accessed here. The preparations for the conduct of the proof-of-concept, clinical trial, RADIAL, are in full swing. In this trial, participants living with type 2 diabetes will switch their basal insulin to a different one. Participants in the remote arm will receive all training and documentation without having to visit a trial site. The results in this arm will be compared to results in a conventional arm, and a hybrid one. Last month, two members of the Patient Expert Panel (PEP) attended the in-person Annual Meeting. The Patient Expert Panel was set up early in the project to reflect the needs and preferences of people living with diabetes. Since the beginning of the project, PEP members have provided valuable input across many of the project’s aspects including the design of the trial and its logistics.
On the first day, PEP Member, Erik Werson, participated in a Panel on Return of Data to Patients. There he emphasized the need for healthcare professionals to understand the person in front of them and support them accordingly. “I am eager to know and learn, but most people are not, and are not interested in information that does not give them real insights. Also, if I go to my GP, I probably know more about my chronic disease than they do. To help me, translate trial data, the healthcare professional needs to do a deep dive into how that data can be valuable to me.”
On the second day of the meeting, a Panel on Agreement with the Regulatory Feedback on DCT Approaches took place, during which Kostas Tagkalos, another PEP member, pointed out that “If a patient has a regular GP, the patient will ask feedback and comments relating to a potential trial. The relationship between the patient and the GP is a strong one because the GP is the patient’s first line of contact for all aspect of their care, and this must not be ignored when planning recruitment, as a patient will not easily dismiss their GP’s view or act without first obtaining their advice.”
The Clinical Trial Application has now been submitted in the European Union via the Clinical Trials Information System (CTIS). Part I has received positive feedback. Part II is currently under review, as well as the submission to the UK authorities. The First Patient First Visit-milestone is expected towards the end of the year or in early 2023.
The next meeting, the semi-annual meeting, will take place at the end of March, 2023, in Valencia, Spain. All PEP members look forward to the next steps in the project and the semi-annual meeting!