From Idea to Impact: Your Partner in Clinical Research That Matters
Beyond its role in supporting clinical studies, the DCR contributes to advancing the methodology of clinical trials through tool development, education, and collaboration at the national level.
In 2025, the DCR statistics team developed and advanced several methodological tools:
randotools
an R package (released on CRAN) for generating randomisation lists in formats directly compatible with DCR databases, including functionality to assess minimisation procedures (developed with support from the SCTO Statistics and Methodology Platform)
harmBounds
a novel, event-based approach to safety monitoring in randomised clinical trials, currently implemented in an R package under development, enabling calculation of stopping probabilities, definition of safety boundaries, and visualisation of monitoring processes
DxPower
an R package in development (supported by an SCTO programming grant) for sample size and power calculations in confirmatory diagnostic accuracy studies, addressing co-primary endpoints (sensitivity and specificity) while accounting for disease prevalence
National Collaboration
In July 2025, Swissmedic launched a public consultation on the draft ICH E20 guideline on adaptive clinical trials. Under the umbrella of the SCTO Statistics & Methodology Platform, a working group was established to review the draft and prepare joint feedback. The group included statisticians from DCR Bern as well as from HOCH Health Ostschweiz, the Swiss Cancer Institute, the University of Zurich, and the University of Basel.
Comments addressed key methodological aspects, including trial integrity, simulation requirements, sample size adaptations, and the clarity of terminology and documentation standards. A consolidated set of methodological comments was submitted to Swissmedic on behalf of the SCTO network.