Real world evidence: Perspectives from a European Society of Cardiology Cardiovascular Round Table with contribution from the European Medicines Agency
Methodological detailsEuropean Society of Cardiology (ESC) Cardiovascular Round Table with European Medicines Agency (EMA) contribution
- ESC Cardiovascular Round Table with EMA contribution
Recommendations
As issued by the authors
ESC supports the use of real world data (RWD) with national cardiac societies, regulators and industry for quality-of-care improvement, registry-based randomised controlled trials (RCTs) (R-RCT) and safety surveillance of novel drugs and devices
EMA is developing systems and processes to enable use of RWD in trial planning, defining clinical contexts and enhancing outcome assessments
RWD can help measure the impact of regulatory actions (e.g. contraindications, restricted indications) via medicines use patterns over time across EU Member States
Common data models, which standardise format and content, may facilitate RWD use by allowing data from different health systems to be analysed together
Original publication
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