On 6 December 2021, 15:00 – 17:00 CET, our partner European Clinical Research Infrastructure Network (ECRIN), in the frame of WP10 – Quantification of healthcare, industry and socioeconomic effects, is organizing the Statistical environment for in-silico trials e-workshop. The e-workshop will bring together experts from in-silico research as well as experienced biostatisticians, data managers and data scientists with the aim to discuss and specify the requirements for the implementation of an R-statistical analysis environment for planning and managing in-silico-trials and to explore implementation strategies, along with open issues, options and hurdles to overcome. The e-meeting will also leverage the participation of in-silico experts of the other H2020 in-silico trial projects, namely the In Silico World, SimInSitu, and SimCardioTest consortia.

Different tools have been developed to support the statistical management of in-silico trials (e.g., QSP, Simulo, Hect, InSilico trial platform, UISS). SIMCor, addressing the challenges of cardiovascular implantable device manufacturers, put in place a standardized validation process and sensitivity analysis to guarantee statistical credibility for in-silico tests.

To cover its full cycle, it also aims to implement a flexible and openly available R-statistical analysis environment for planning and managing in silico trials within its Virtual Research Environment (VRE). The requirements for virtual cohort generation and in-silico trials defined by SIMCor can only be partially fulfilled by the existing tools. In order to cover the full development, verification and validation cycle, a necessity is seen to implement a more flexible and openly available statistical environment for in-silico trials.

It is expected that the solution will be generalizable to other in-silico projects. The specification and analysis of in-silico trials in SIMCor will be performed with open-source software for statistical planning and analysis, such as R and RStudio. The R-statistical environment provided for SIMCor should cover the following functionalities: specification of trial design and of trial data structure, importing virtual cohort data to the R-environment, analysis of in-silico trial, assessment of results, export of results to the computing environment and systematic variation of in-silico trials.