As of 2026, the regulatory landscape for digital clinical trials across Europe has matured significantly, with 65% of EU member states reporting full implementation of supporting frameworks. Denmark’s updated guidance contributes to this momentum, aligning the nation with the growing consensus on how to safely conduct decentralised research.
The Danish Medicines Agency’s revised framework specifically addresses cross-border participation, enabling patients to enrol in trials across EU borders. This development reflects broader adoption patterns: 25% of member states are currently developing their frameworks, while 10% remain in the planning stage. The cross-border provisions are particularly transformative for rare disease research, where patient populations are geographically dispersed and international collaboration is essential for adequate trial recruitment.
Read the full article on GMJ Newsroom.
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