Primum Non Nocere, Secundum Simulare: A New Era in Clinical Trials
In silico trials (ISTs) and computational medicine are poised to transform medical device development and regulation, embodying the principle of "Do No Harm by Design". This talk explores how ISTs can address the limitations of traditional clinical trials, including high costs, lengthy timelines, and safety concerns. By simulating device performance in virtual environments, ISTs offer a pathway to accelerate innovation, reduce expenses, and enhance patient safety. We'll examine compelling examples demonstrating ISTs' ability to replicate and extend traditional trial insights, tackling challenges like off-label use, device-dependent healthcare inequities, and optimal treatment stratification. Emphasising collaboration between regulators, industry, and patients, we'll discuss how ISTs can foster safer, more sustainable medical innovation.