RADIAL, a test run for clinical trials of the future
The Trials@Home consortium is planning a unique clinical trial, a proof of concept study, called RADIAL to test how clinical trials can be run in the future.
Regulatory Agencies React
Trials@Home consulted the European Medicines Agency’s (EMA) Innovation Task Force (ITF) & BfArM
The meeting objectives were to explore the regulators’ expectations of data, regardless of where and how it is collected (e.g., at home or in the clinic), and to discuss the methodology for the RADIAL trial.