Clinical Operations — Christine Biaggi
Improving Structures – Advancing Clinical Research Efficiently
For the Swiss Cancer Institute (SCI), 2025 was a year of growing trial numbers and stable operational performance. Clinical Operations managed 64 active trials, 36 of which were open to patient enrolment. The portfolio was strategically expanded with the launch of 13 new trial projects.
A total of 791 patients were enrolled in trials, bringing the Institute close to its target of 800. At the same time, 11 trials were closed to enrolment as planned. These figures demonstrate both the stability of trial operations and the ongoing development of the trial portfolio.
Process Optimisation and Operational Management
Alongside this quantitative growth, internal processes were systematically reviewed and further refined. The SCI has been pursuing the goal of making clinical research more efficient and resilient and faster since summer 2024.
During the reporting year, several process adjustments were implemented to improve transparency, traceability and oversight in project management. This created a structural foundation for managing increasing complexity effectively.
Introduction of the CTMS (Clinical Trial Management System)
A key milestone was the introduction of a new CTMS (Clinical Trial Management System). The previous solution no longer met the growing requirements for data integrity, reporting and portfolio overview.
The new CTMS harmonises core processes, improves the real-time overview of ongoing trials and increases the transparency of key performance indicators. All trials are currently being migrated to ensure that the system’s expanded functions can be applied consistently.
Enhancing the Statistical Infrastructure
Significant structural enhancements were also implemented in the area of statistics in 2025. R was validated for production use in May. The Institute’s second in-house R package, summarySCI, was published on CRAN in October. In addition, the SCI once again received the programming grant from the SCTO (Swiss Clinical Trial Organisation).
These steps improve the reproducibility, standardisation and efficiency of statistical analyses and contribute to the methodological quality of clinical research.
National Collaboration and PPI
Collaboration with the SCTO was further expanded during the reporting year. The SCI participated in the R validation project, the review of the ICH E20 guideline and the development of a joint CDMS infrastructure.
In addition, efforts were made to expand national PPI activities. Thus, PPI is now structurally embedded in the SCI’s research strategy.
Data Infrastructure and Interoperability
The interface between the SODI (Swiss OncoData Infrastructure) project and BioMedIT was implemented using the SPHN Connector at the end of the year. This ensures the secure, interoperable and efficient transfer of clinical data.
The expanded infrastructure will also enable non-university hospitals to participate in national data initiatives in a structured manner in the future, thereby facilitating collaboration across the Swiss research landscape.
Clinical Operations: Christine Biaggi, Clinical Operations Officer