An open source statistical web application for validation and analysis of virtual cohorts

Abstract

Abstract The conventional approach to developing medical treatments and medical devices usually covers pre-clinical and in-vitro investigations, in-vivo animal studies and clinical trials with humans. In-silico trials and virtual cohorts present a promising avenue for addressing the challenges inherent in clinical research and improving its efficiency. Despite considerable advancements in the field of in-silico trials, several notable gaps and challenges still need to be addressed, one is the limited availability of open and user-friendly statistical tools to support the specific analysis of virtual cohorts and in-silico trials. In the EU-Horizon funded project SIMCor we have developed a web application, providing a R-statistical environment supporting the validation of virtual cohorts and the application of validated cohorts for in-silico trials. It provides a practical platform for validating cohorts and has implemented existing statistical techniques that can be applied to compare virtual cohorts with real datasets. It is fully open, generic and menu driven and provides user guidance and help (https://github.com/ecrin-github/SIMCor, https://zenodo.org/records/14718597).The tool has been developed according to specified user requirements and has been extensively tested and validated. Important next steps are to gain more experience with the tool in other domains and research environments and to extend its functionality.