AUTHOR=Craig Morgan , Gevertz Jana L. , Kareva Irina , Wilkie Kathleen P. TITLE=A practical guide for the generation of model-based virtual clinical trials JOURNAL=Frontiers in Systems Biology VOLUME=3 YEAR=2023 URL=https://www.frontiersin.org/journals/systems-biology/articles/10.3389/fsysb.2023.1174647 DOI=10.3389/fsysb.2023.1174647 ISSN=2674-0702 ABSTRACT=

Mathematical modeling has made significant contributions to drug design, development, and optimization. Virtual clinical trials that integrate mathematical models to explore patient heterogeneity and its impact on a variety of therapeutic questions have recently risen in popularity. Here, we outline best practices for creating virtual patients from mathematical models to ultimately implement and execute a virtual clinical trial. In this practical guide, we discuss and provide examples of model design, parameter estimation, parameter sensitivity, model identifiability, and virtual patient cohort creation. Our goal is to help researchers adopt these approaches to further the use of virtual population-based analysis and virtual clinical trials.