Diabetes chosen as therapeutic area for the pan-EU pilot study of Trials@Home
Last update: 26/06/2020
IDF Europe is one of the consortium partners in an Innovative Medicines Initiative 2 project, Trials@Home. This five-year project, which officially started in September 2019, explores the opportunities of moving clinical trials from the traditional clinic setting to the participant’s immediate surroundings. These 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. RDCTs aim to help broaden participation in clinical trials from larger, more diverse and remote populations as well as provide results that are more representative, because the data is collected in the daily context of the participant (Real World Evidence).
As part of the project, a pan-European pilot study will be undertaken which will help assess fully and hybrid RDCT models vs traditional approaches as well as present and refine key performance indicators (KPIs) to qualify and quantify the flow of activities, subject perception, cost, quality and compliance. After a thorough review of several therapeutic areas (TA), the consortium decided to focus the pilot study on diabetes. The decision was based on a number of criteria, such as the study population, clinical value of the study, fit of the TA for testing the RDCT approach, and safety. Beyond its involvement in the pan-EU pilot, IDF Europe is also engaged in Work Package 5, communication, dissemination, and stakeholder engagement.
More information about the project can be found here.
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.