DARWIN EU® is calling for new data partners

By HEOR Staff Writer

April 3, 2023

DARWIN EU®, a network for data analysis and real-world interrogation, has successfully completed its first year of operation. The network has onboarded ten data partners and initiated four studies using real-world data from across Europe to better understand diseases, populations, and the uses and effects of medicines. DARWIN EU® generates real-world evidence to support the decision-making of EMA scientific committees and national competent authorities in EU Member States throughout regulatory processes. The network plans to onboard ten additional data partners and initiate around 16 studies in 2023. The first four studies demonstrate the benefits of DARWIN EU®, including faster performance, increased capacity, and lower costs. Results from completed studies have been provided to relevant EMA committees to support their future work. DARWIN EU® is also collaborating with stakeholders and participating in a pilot for the European Health Data Space (EHDS), ultimately delivering around 150 RWE studies per year by 2025.

Reference url

Recent Posts

Tovorafenib clinical assessment
Tovorafenib Clinical Assessment Outcomes and Methodological Challenges

By João L. Carapinha

June 9, 2026

The Tovorafenib clinical assessment conducted under the EU Joint Clinical Assessment process has exposed critical shortcomings in the evidence base for treating BRAF-altered pediatric low-grade glioma. Despite the therapy’s potential, reviewers concluded that robust comparative data is absent for...
Levacetylleucine A-T treatment
Transformative Impact of Levacetylleucine A-T Treatment in Rare Neurodegenerative Disease

By HEOR Staff Writer

June 8, 2026

Levacetylleucine A-T treatment has delivered compelling Phase III results, producing statistically significant and clinically meaningful improvements in ataxia severity and daily function for both pediatric and adult patients with ataxia-telangiectasia (A-T). The
Parkinson's Cognitive Measurement
Parkinson’s Cognitive Measurement and the Impact of Precision on Forecasting

By João L. Carapinha

June 8, 2026

Parkinson's Cognitive Measurement has emerged as the decisive constraint on our ability to forecast cognitive decline in Parkinson disease. A major new analysis shows that even the most advanced machine learning models deliver only chance-level accuracy when predicting individual cognitive trajec...