Produced by Premier Research and InSilicoTrials
In this white paper, we explore the concept of synthetic control arms (SCAs) and their potential to transform the clinical trial landscape. We begin by providing an overview of the emergence of SCAs before delving into the workflow of constructing an SCA. We discuss the methodology used in constructing virtual patients and examine the benefits of SCAs, including their potential to accelerate timelines, reduce risks, increase efficiency, and reduce patient enrollment, thus resulting in cheaper and faster trials. We discuss the challenges of SCAs, including issues related to model validation, regulatory approval, statistical, and virtual patient methodology. We offer insights into regulatory considerations surrounding SCA use and briefly highlight a global initiative to establish best practice guidelines for in silico modeling and simulation in clinical trials, which includes input from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).