One Research Objective, Many Realities: Mapping Data Availability and Governance Diversity in Oncology Research
Author(s)
Andrea Roncadori, BSc, MSc1, Luisa Lopes Conceicao, Msc2, Teresa Mota Garcia, MD2, Juho Lähteenmaa, Msc3, Kevin Tittel, Msc4, Andreas Bjerrum, MD5, Ilaria Massa, Msc6.
1Outcome Researcher, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST IRCCS, Meldola, Italy, 2Instituto Português de Oncologia do Porto, Porto, Portugal, 3Comprehensive Cancer Center, University of Helsinki & Helsinki University Hospital, Helsinki, Finland, 4The Netherlands Cancer Institute [NKI], Amsterdam, Netherlands, 5Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark, 6IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy.
1Outcome Researcher, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST IRCCS, Meldola, Italy, 2Instituto Português de Oncologia do Porto, Porto, Portugal, 3Comprehensive Cancer Center, University of Helsinki & Helsinki University Hospital, Helsinki, Finland, 4The Netherlands Cancer Institute [NKI], Amsterdam, Netherlands, 5Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark, 6IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Meldola, Italy.
OBJECTIVES: ONCOVALUE is an EU-funded project aimed at unlocking the full potential of hospital-based real-world data (RWD). In this context, this study was performed for assessing the availability of patient-level data across hospital/cancer centers and the regulatory conditions for their use.
METHODS: A structured survey was distributed to ONCOVALUE clinical partners and other European cancer centres. The survey investigated the presence and research use of various data types, including clinical, demographic, patient-reported outcomes (PROs), cost and imaging data, alongside data sharing practices, and ethical and legal requirements.
RESULTS: All centers (N=10) reported access to relevant clinical and demographic characteristics. However, significant variability was observed in the availability of PROs and cost data. Specifically, only six centers (60%) collected PROs. Similarly, although direct cost data were commonly available, only three centers (30%) reported access to indirect cost data, reflecting uneven granularity in economic information. While all centers indicated that data were or could be used for research, access was conditional on ethical approval and other institutional permits. Data sharing was permitted mainly conditional to pseudo-anonymization or anonymization. Furthermore, when asked about participation in federated data analysis and the use of artificial intelligence (AI) tools, seven centers (70%) indicated that a Data Transfer Agreement (DTA) would be necessary, and eight (80%) reported that specific permits would be required for installing AI-based software. Estimated approval timelines ranged from less than a month (20%) to 4-6 months (10%).
CONCLUSIONS: While all surveyed centers had a general capacity to contribute clinical data for federated oncology research, considerable heterogeneity remains in terms of data availability - particularly PROs and indirect costs - as well as in legal, ethical, and organizational requirements. These findings emphasize the need for adaptive governance strategies to ensure consistent participation and harmonized data-sharing across institutions in large-scale, multi-center, multi-country health data initiatives.
METHODS: A structured survey was distributed to ONCOVALUE clinical partners and other European cancer centres. The survey investigated the presence and research use of various data types, including clinical, demographic, patient-reported outcomes (PROs), cost and imaging data, alongside data sharing practices, and ethical and legal requirements.
RESULTS: All centers (N=10) reported access to relevant clinical and demographic characteristics. However, significant variability was observed in the availability of PROs and cost data. Specifically, only six centers (60%) collected PROs. Similarly, although direct cost data were commonly available, only three centers (30%) reported access to indirect cost data, reflecting uneven granularity in economic information. While all centers indicated that data were or could be used for research, access was conditional on ethical approval and other institutional permits. Data sharing was permitted mainly conditional to pseudo-anonymization or anonymization. Furthermore, when asked about participation in federated data analysis and the use of artificial intelligence (AI) tools, seven centers (70%) indicated that a Data Transfer Agreement (DTA) would be necessary, and eight (80%) reported that specific permits would be required for installing AI-based software. Estimated approval timelines ranged from less than a month (20%) to 4-6 months (10%).
CONCLUSIONS: While all surveyed centers had a general capacity to contribute clinical data for federated oncology research, considerable heterogeneity remains in terms of data availability - particularly PROs and indirect costs - as well as in legal, ethical, and organizational requirements. These findings emphasize the need for adaptive governance strategies to ensure consistent participation and harmonized data-sharing across institutions in large-scale, multi-center, multi-country health data initiatives.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD130
Topic
Real World Data & Information Systems
Topic Subcategory
Distributed Data & Research Networks, Health & Insurance Records Systems, Reproducibility & Replicability
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology