Hosted at Duke University, this summit will gather leading experts, researchers, and practitioners in medical imaging and therapy using in silico virtual trials and digital twins in medicine. The complexity and diversity of medical technologies and applications have continued to accelerate, outpacing our ability to optimize their design and use. This has become a significant challenge across the spectra of scientific inquires, product designs, and clinical applications. The evaluation of new innovations would ideally be achieved through clinical trials. However, such trials are often not feasible or even definitive due to ethical limitations, expense, time-requirements, difficulty in accruing enough subjects, or the fundamental lack of ground truth. In silico or Virtual Trials (VT) provide an alternative approach to assess the impact of such innovations on patient care. They offer a new truth-based approach to conduct medical trials that can be made to be clinically relevant, timely, and accurate while reflecting the variabilities of human bodies and complexities of technologies, providing answers that would otherwise be impractical or unattainable. A VT consists of:

1. Realistic populations of computational patients spanning ages, sexes, and races.
2. Detailed models of clinical technologies or applications, and
3. Computational representations of the outcome assessment.

Envisioned as the first in a series, the objective of this Summit is to consolidate the latest developments, summarize the current status, and envision the future prospects of in silico virtual trials and digital twins in medicine. A two and a half – day event will include plenary speakers, proffered presentations, and perspectives from the industry, regulatory bodies, and funding agencies. The event is meant to serve as a forum to discuss methods, opportunities, challenges, limits, and future direction of virtual trials in medicine.