Innovative Medicines Initiative Launches ‘Trials@Home’

The so-called Remote Decentralised Clinical Trials (RDCTs) make use of new – digital – innovations and enable participants to visit a clinical trial centre less frequently, if at all. This makes it easier for larger, more diverse and remote populations to participate in clinical trials. These trials are expected to be conducted faster, more efficiently, and provide results that are more representative, because the data is collected in the daily context of the participant (Real World Evidence). The research to be conducted includes an inventory and evaluation of existing and new techniques for use in RDCTs as well as a pan-European pilot trial.

An international consortium of 31 members has received Innovative Medicines Initiative funding and will develop and test remote decentralised methods to streamline data collection, participant recruitment and retention. The project will run for 5 years and will be coordinated by University Medical Center Utrecht and Sanofi. Lygature will supply the project with a dedicated platform for internal communication, and assist the coordinator with various Program Management tasks.

The project will involve an inventory and evaluation of studies already conducted with remote elements, research into available technologies and research into the legislation and ethical requirements in different countries in the field of enabling technologies. There will also be a study in which the team hopes to determine how different approaches (classical site-centred trial methodology, remote participation, hybrid model) compare and which approach produces the best result in terms of participant satisfaction, inclusion rate, costs, data quality and more.

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 831458. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.