SP5 - GUIDE-IBD

Biostatistics and statistical modelling

Subproject SP5 is responsible for the biostatistical analysis of this randomized clinical trial, it also supports the other subprojects regarding methodological aspects, i.a. in the preparation of the study protocol and case report forms according to good clinical practice (ICH-GCP). SP5 is responsible for the randomized assignment of patients in one of the two study arms “best standard care” or “molecular medicine care”.
The two main tasks of SP5 are the analysis of the primary and secondary endpoints of this study and the development of predictive models for therapy response based on biomarkers. The randomized trial will demonstrate whether additional markers from blood serum, biopsies and stool samples as well as e-health-related data lead to an improved treatment response (mucosal healing / clinical remission). In close collaboration with the other subprojects, predictive molecular markers and clinical variables will be identified and subsequently mathematical models will be developed to predict treatment response. Finally the markers used in the molecular medicine board with the largest prediction value should be determined by machine learning algorithms to make adapted, reduced marker panels for therapy prediction available. This should optimize the applicability for an individual therapy adjustment.