Digital Twins: A Futuristic Artificial Intelligence Methodology for Design and Analysis of Clinical Trials
Received Date: May 22, 2023; Published Date: May 26, 2023
This paper introduces the recently-proposed clinical trial design known as “digital twins”. This design utilizes a single arm where all patients receive the experimental treatment. A digital twin of each patient is constructed by artificial intelligence methods from thousands of real-world data records, physiologic and molecular characteristics and the patient’s baseline data. Presumably the only difference between the patient on the clinical trial and his/her digital twin is the experimental treatment. A matched pair analysis is now performed comparing each patient’s outcome with that of the digital twin. Several methods of analysis are presented. The role of digital twin methodology in drug development is discussed including the potential of its use as a pivotal trial for drug approval.