The arrival of digital twins and in silico trials in drug development

This perspective piece examines the emerging role of digital twins and in silico trials in drug development, arguing that computational tools capable of simulating human biology at scale have the potential to fundamentally reshape how therapies are evaluated before and alongside traditional clinical trials. The authors outline the current state of these technologies, their promise for generating regulatory-grade evidence, and the critical gaps that remain between their theoretical potential and their practical adoption. Central to the argument is that realizing this potential will require deliberate input from regulators and meaningful engagement from the public sector.

The piece arrives at a pivotal moment, as pressure mounts to accelerate drug development timelines while reducing reliance on costly and ethically complex animal and early-phase human trials. By calling for comprehensive regulatory reform alongside technological advancement, the authors make a compelling case that digital twins and in silico trials are not merely futuristic concepts but near-term tools requiring urgent infrastructure investment to ensure their safe, equitable, and scientifically rigorous adoption in clinical and regulatory practice.