Digital patient simulation is transforming clinical development by using advanced modeling, real-world data, and foundation models to create richer representations of patient journeys. Approaches such as external comparators, synthetic controls, digital twins, and synthetic data can help inform trial design, improve feasibility, support prediction, and enhance evidence generation. Digital twins create patient-level models that simulate individual trajectories, while synthetic twins aggregate these simulations into comparator groups. These methods do not replace randomized trials but can reduce uncertainty, address challenges in rare or complex populations, and potentially reduce placebo exposure when appropriately validated. As foundation models advance, they offer new opportunities to sca

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