The ENRICHMENT project was a pioneering initiative launched by the U.S. FDA and Dassault Systèmes in 2019, exploring the possibility of using virtual twins of patients to evaluate safety and effectiveness of a new medical devices in The FDA Enrichment In Silico Clinical Trial Project.
An international, multidisciplinary team was assembled from academia, industry and clinical practice and government to evaluate the science necessary to demonstrate ISCT credibility for regulatory purposes. Over 5 years, three working groups, under the oversight of three advisory councils meticulously evaluated and documented the challenges, collaborating virtually on the 3DEXPERIENCE platform.
Upon completion, the group created and published a detailed guidebook for the regulatory use of ISCT for industry to follow, illustrated through the hypothetical ICST example used in the project. The final full publication is available here.
In addition, the supplemental material represents a case study from the ENRICHMENT project, illustrating the development of a hierarchical credibility assessment framework for in silico clinical trials (ISCTS) using a generic edge-to-edge mitral valve repair device. It details the use of physics-based and data-driven models to simulate patient-device interactions, refine enrollment criteria, and assess model credibility, while addressing limitations in validation for a regulatory application.
