Synthetic Data for Regulatory and Payer purposes | REDDIE Webinar
On July 18th 2024, REDDIE launched its first webinar entitled “Any resemblance to real persons is purely coincidental: Synthetic data for regulator...
Randomised controlled trials (RCT) are the cornerstone of evidence-based medicine. However, the digitisation of real-world data (RWD) including data from devices, wearables, and electronic health records in large national registries provides opportunities to demonstrate efficacy and safety of innovative technologies including drugs, devices, diagnostics, and digital health. These data are particularly relevant to long-term conditions such as diabetes mellitus, where drugs, lifestyle interventions, and digital technologies often work together.
“In REDDIE, we will first define a typical target parameter of an RCT and then look for all people exposed to the same intervention in four comprehensive European real-world databases (Sweden, Denmark, Germany and England).
In this way, we ‘recreate’ the RCT trial within the real-world databases. Due to the large amount of real-world data we have available, we will get much faster answers to our research questions, tested in a much bigger cohort than this would ever be possible with RCTs.”
Dr Julia Mader, Medical University of Graz, REDDIE coordinator