Digital Twins: A Futuristic Artificial Intelligence Methodology for Design and Analysis of Clinical Trials

This paper introduces the recently-proposed clinical trial design known as “digital twins”. utilizes a single arm where all patients receive experimental treatment. A digital twin of each patient is constructed by artificial intelligence methods from thousands real-world data records, physiologic and molecular characteristics patient’s baseline data. Presumably only difference between on his/her matched pair analysis now performed comparing outcome with that twin. Several are presented. The role methodology in drug development discussed including potential its use pivotal for approval.