New Project started under in the imi – innovative medicines initiative
With November 2019 we are part of a consortium of the project with the name “Trials@Home”. The project has been funded under the EU innovative medicine initiative (imi).
The aim of the project is to provide a framework for remote decentralized clinical trials.
The official summary says: “In a conventional clinical trial, patients have to make regular trips to the clinic for check-ups to monitor their condition. Many patients are understandably put off by the distance to the clinic and how often they would be expected to make the trip, and many patients who initially join trials drop out for logistics reasons. Digital technologies and wearable devices mean it is now possible to assess patients remotely – while they are at home, or going about their daily lives. If used during clinical trials, they could dramatically reduce the number of times patients are expected to visit the clinic.
Trials@Home aims to explore the potential of digital technologies for use in ‘remote decentralised clinical trials’ (RDCTs). They will develop and test methods to streamline data collection as well as patient recruitment and retention. They will also discuss RDCTs with patients as well as regulators, payers, health technology assessment bodies (HTAs) and ethics bodies, to ensure that the project outcomes can be implemented. At the heart of the project is a study in which one group of patients will have the conventional clinical trial experience with regular clinic visits; a second group of patients will participate completely remotely; and a third group will follow a partly conventional / partly RDCT approach. The project will use the results of this study to identify which approaches are best for patient satisfaction, data quality and other parameters.
If successful, RDCTs could make it easier to recruit and retain larger numbers of patients, including people from groups that are often under-represented in trials. Furthermore, as data collection would be more or less continuous, the results would be more reliable and more representative of the real world.”
I am looking forward to this challenging but innovative project. The eHealth Institut of the FH Joanneum is leading the Technical Workpackage and is responsible for managing the selection as well as the quality scan of technology for all the phases relevant in RDCTs.
The project is supported by all major pharmaceutical industries and associations in Europe, universities, research institutes as well as a selection of small, medium as well mid-size enterprises. The project is running for 5 years and has a total budget of 38 Million Euro.