Within Trials@Home we explore the concept of decentralized clinical trial approaches, or DCTs. We are now at the stage of the project that our European proof of concept study, RADIAL, started with activation of the first sites. RADIAL aims to test out whether future clinical trials can be successfully run from participants’ homes rather than hospitals or clinics.
The goal of RADIAL is to assess the scientific quality and operational feasibility of fully decentralized and hybrid approaches in comparison with traditional, site-based trials. RADIAL will evaluate the acceptability of DCTs in terms of safety, data quality and medical endpoints, as well as explore potential benefits to DCT approaches, such as better recruitment, lower participant and site burden, less interference with routine clinical practice, or a more representative study population. The results of RADIAL and other project outputs will be used to draft recommendations for the implementation and conduct of DCTs in Europe.
As RADIAL anticipates the start of participant recruitment this month, we’re happy to explain what we want to achieve with RADIAL, how all of the work was done in co-creation with patients and regulators and give an overview of the protocol and the technologies that we’re using.