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Multi-centre real-world data research collaborations are essential in radiation-induced toxicity prediction modelling in order to achieve larger and more diverse datasets, especially for rare toxicities such as mandibular osteoradionecrosis (ORN). The PREDMORN international multi-centre study was developed to achieve more statistically robust and generalisable conclusions than the existing published studies on ORN modelling. We describe the main challenges and limitations encountered in the data sharing process and make some recommendations based on the PREDMORN study experience.

The PREDMORN study was designed as a retrospective case-control study involving five European and one US teaching hospitals. The study hypothesises that the risk of developing ORN can be accurately predicted on an individual level with NTCP models based on dosimetric parameters and clinical and demographic variables. The participating centres joined the study at different time points over a period of 11 months. The data transfer process was initiated in parallel to protocol development (Humbert-Vidan et al. 2022) and local data collection processes.

The use of each collaborating centre’s data is dependent on obtaining appropriate local governance/ethics approval and data transfer agreements (DTA). We initially explored a ‘Joint Controllers’ data transfer approach in order to facilitate a joint use of the data by all parties for the study. However, from a legal perspective, a ‘Controller to Controller’ approach was considered more efficient. For expediency, it was decided to proceed with individual DTAs between each participating centre and the receiving centre, seeking permission for the receiving centre to use the data for the study only.  Data received under these DTA’s cannot be shared with other participating centres for others’ own ORN studies, thus limiting collaborative efforts. Considerations towards data protection and anonymisation varied across centres, from pseudonymised Personal Data to fully anonymised data, the latter being out of GDPR’s scope.

Unlike in clinical trials, multi-centre studies using real world data benefit from larger patient diversity. However, data collection can be challenging in late toxicities such as ORN if previous patient consent was not obtained. The different attitudes towards data sharing and acceptability of the type of DTA across all centres prolonged the negotiation between legal teams. We recommend initiating the legal process for the DTAs at an early stage, during protocol development and local data collection, to reduce delays. GDPR contains mechanisms and requirements for sharing Personal Data within and outside the EU, but consistency is lacking. Standardisation of the data sharing process to facilitate multi-centre collaborations would reduce unnecessary delays and costly resources and promote more robust clinical research studies, thus resulting in improved quality of patients care.