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BACKGROUND: The rapid advancement of medical technologies presents significant challenges for researchers and practitioners. While traditional clinical trials remain the gold standard, they are often limited by high costs, lengthy durations, and ethical constraints. In contrast, in-silico trials and digital twins have emerged not only as efficient and ethical alternatives but also as a complementary technology that can extend beyond classical trials to predict and design new strategies. The successful application of digital twins in industries like nuclear energy, automotive engineering, and aviation underscores their potential in human health. METHODS: In April 2024, Duke University hosted the first international summit on Virtual Imaging Trials in Medicine (VITM). The summit brought together over 130 experts from academia, industry, and regulatory bodies to discuss the latest developments, challenges, and future directions in this field. The event featured plenary speakers, presentations, and panel discussions, emphasizing the integration of clinical and in-silico methods to enhance medical evaluations. RESULTS: Key takeaways included the necessity of diverse and realistic digital patient representations, the integration of physics and biology in simulations, and the development of robust validation frameworks. The summit also highlighted the importance of regulatory science and the establishment of Good Simulation Practices to ensure the credibility and reliability of virtual trials. CONCLUSION: The key discussions and insights from the VITM summit underscore the potential of in-silico trials to revolutionize medical research and patient care through personalized, efficient, and ethical evaluation methods. The collaborative efforts and recommendations from this summit aim to drive future advancements in virtual imaging trials in medicine.
Samei et al. (Tue,) studied this question.