ONCOVALUE will unlock the full potential of real world data (RWD) collected in European cancer hospitals and institutes to ease the decision-making of regulators on cost-effectiveness of novel cancer therapies. To achieve this, we build up data collection and processing capabilities of leading European cancer hospitals to create a high-quality clinical, quality of life, and adverse events data-sources. With the use powerful AI technologies, we will transform unstructured data originating from medical notes and medical images into structured data to enable analytics and real world evidence (RWE). This RWE will be directly available for clinicians for treatment management and for health regulatory and HTA bodies to adopt optimized data-driven methodologies for the effective assessment of medicinal products and digital health innovations. For that, we will provide an end-to-end infrastructure for RWD reporting in health regulatory and HTA decision-making and address the legal constraints in the cancer hospitals to ensure secure and legal access to RWD. Furthermore, ONCOVALUE will ensure the implementation of the developed guidelines and methodologies, by providing trainings for the collection and management of high-quality RWD in European cancer centres and for the analysis of this data by HTA and regulatory bodies. By opening the door to widespread regulatory and HTA integration of RWD, ONCOVALUE will lead to safer, more efficient, and affordable therapies, technologies, and digital solutions for (personalised) cancer care. As such, ONCOVALUE is positioned to contribute to increased cost-effectiveness and subsequent sustainability of cancer care. Systematic collection and evaluation of the patient reported outcomes will lead to improved well-being of the patients. Subsequently, on the long-term implementation of value-based cancer care at European cancer hospitals will aid in reducing the growing burden of cancer treatment in the EU and worldwide.