Project Funding Details

In Europe, survival is worse for rare cancers than for common cancers1. Research in rare cancers is hampered by low patient numbers, dispersed clinical data and tumor samples and a limited number of experts per rare cancer diagnosis. A better understanding of the biology, optimal detection and diagnosis and treatment options may lead to improved patient care and outcomes. The harmonization and combination of real-world data from centers specialized in rare cancers can provide unique insights that no single center or registry will be able to produce. With the aim to promote data and knowledge sharing for rare cancers, the European reference Network on rare adult solid cancers (EURACAN) has initiated a European patient registry (EU project STARTER2). STARTER is exploiting the collaborative networking of EURACAN centers of expertise across several EU member states and it is focusing on a limited number of rare adult solid cancers. To include centers into the federated data network, it is struggling to cope with different technology and data standards, data management systems and infrastructures, legal frameworks, data privacy and data governance policies across EURACAN countries as well as different views on governance on data sharing for research. Furthermore, both at the coordinating organizations as well as at the participating centers, human and financial resources are needed to ensure sustainability of a European rare cancer clinical registry. The process of on-boarding centers to the registry is complex and time and resource consuming. It involves bi-lateral discussions on tailored agreements on data transfer, technology usage and data access. Currently, the team of the coordinating center (IT, legal and administration) is overwhelmed and will be unable to support the growth of the registry at an ambitious pace. Especially, after the end of STARTER early 2023, the path forward is unclear. To address these organizational, legal, financial and practical challenges, in BlueBerry we deliver a detailed and validated plan on how to effectively and timely maintain a sustainable, scalable and impactful data infrastructure for rare cancers. The blueprint addresses the four major challenges identified in STARTER: 1. [Registry Governance] A dedicated and scalable organizational governance and legal structure, positioned to bring value to patients, participating centers and clinicians, researchers, policy makers and other stakeholders. With an appropriate legal structure, data usage & access can be governed – which creates transparency for all stakeholders in the network. 2. [Technological] A vision on effective data capture, sharing and analyses, acknowledging the heterogeneity of IT landscapes at the participating centers and leveraging upon European and international data standardization efforts. 3. [EURACAN Center and other Data Provider Inclusion] STARTER is working with the EURACAN centers as well as with available database or registry (eg. NETSARC in France, Netherlands Cancer registry) to exploit all available data sources. However, engagement of the different data providers requires commitment of the data providers and involvement of different key actors within the organization (Data Protection Office; IT person, legal etc.). An attractive model to incentive and facilitate the data provider and coordinate the involvement of key actors is needed to engage the data providers. 4. [Financial Sustainability] A business model and plan for economic sustainability of the registry as well as incentivization of participating centers, such that the registry will be a stable infrastructure with reliable access to rich, recent and representative data This blueprint will be designed by (1) reviewing current STARTER set-up from a multi-disciplinary angle, (2) understanding and leveraging best practices in modern and emerging health data infrastructures and collaborations and (3) “learning on the job” by setting up a data infrastructure for Sarcomas. This data infrastructure will create a unique federated data source based on leading and emerging sarcoma datasets within Europe (i.e. the sarcoma database at Isututo Nazionale dei Tumori3; NETSARC (French national network on sarcomas4; Grupo GEIS5, Austrian Sarcoma Registry, Netherlands Cancer Registry, Scandinavia6). It will be the first time these datasets will be harmonized and combined. At the end of the project, BlueBerry will deliver: 1. A validated and co-created proposal for an organizational structure for the EURACAN Registry, including a financial plan and resource plan dedicated to maintain, expand and service the EURACAN Registry. 2. A co-created legal framework, that would simplify and accelerate healthcare partner inclusion. 3. A proposal and requirements for a technical implementation of the federated registry, including a service and maintenance plan. 4. A financial sustainability plan, including agreements on a detailed fee-for-service transaction system for incentivizing centers to participate in the registry and to make data available for studies, as well as technical specifications to implement such broker system. 5. A trial implementation of a federated sarcoma registry and execution of a first use case.

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