HONEUR showcases how Europe can unlock the value of real-world data through real-world evidence to inform decisions, improve patient outcomes, and spur healthcare innovation across the continent.

The study is authored by Prof. Roman Hájek and Martin Price of Johnson & Johnson Innovative Medicine, with sponsorship disclosed by Johnson & Johnson.

The LANDMARK study demonstrates RWD value, showing survival gains for newly diagnosed multiple myeloma linked to timely access to high-value treatments such as anti-CD38 antibodies, with 2025 results expanding to more than 31,000 patients across additional countries.

The European Health Data Space, along with initiatives like DARWIN EU, EHDEN, and the HARMONY Alliance, are highlighted as essential for a harmonised, secure, and interoperable health data ecosystem in Europe.

Policy and infrastructure priorities are outlined: build RWD infrastructure with common data standards and interoperable federated networks, invest in digital health and data science, and ensure RWE informs decision-making through robust studies, data quality, and HTA acceptance.

HONEUR is a federated haematology data network spanning 11 countries with 27 data partners and over 80,000 harmonised patient records, enabling Europe-wide studies without centralising sensitive data.

The authors call for collaboration among policymakers, healthcare professionals, patient organisations, and industry to accelerate RWE adoption, improve access to innovation, and enhance patient outcomes across Europe.

RWE complements clinical trials by revealing treatment performance and patient experiences in routine care, helping clinicians translate data into improvements.

Europe faces interoperability and data fragmentation; federated networks like HONEUR enable cross-border analysis while data remain locally stored to protect privacy and comply with GDPR.