Benefit-risk balance of advanced therapies in inflammatory bowel disease

FORECAST
Julien KIRCHGESNER

Development and validation of a framework using multiple sources of real-world data to assess the benefit-risk balance of advanced therapies in inflammatory bowel disease (IBD), based on the linkage of nationwide healthcare databases, electronic health records, and a prospective cohort of IBD patients.

Team presentation

Supported by European funding (ERC Starting Grant), the general objective of the team is to develop a new approach for assessing the benefit-risk balance of advanced therapies in IBD using three sources of real-world data: : (1) the French nationwide healthcare databases (Système National des Données de Santé [SNDS]); (2) electronic health records with the Assistance Publique-Hôpitaux de Paris  Clinical Data Warehouse (EDS AP-HP); (3) IBD dedicated prospective cohort with the SUVIMIC database.

The first objective is to validate algorithms identifying the characteristics and disease activity of IBD in administrative healthcare databases using supervised or unsupervised methods.

The second objective is twofold: (1) to emulate head-to-head clinical trials assessing the effectiveness and safety of advanced therapies for IBD using real-world data; (2) to elicitate patients preferences on the effectiveness and safety of IBD treatment.

The third objective is to integrate these results into a patient-centered clinical decision support system for patients and clinicians and to assess its impact in real life.

This project is based on a multidisciplinary approach, ranging from qualitative approach to artificial intelligence, to clarify the position of each treatment in IBD and disseminate findings to patients and clinicians. The post-marketing drug surveillance framework developed will be applicable not only to future IBD treatments but also to other chronic diseases.