Virtual clinical trials (VCTs), as a computational model-centered tool, are progressively transforming the traditional research and development (R&D) paradigms for drugs and medical devices. With the iterative advancement and integrated application of computer modeling and simulation technologies, artificial intelligence (AI), and digital twin (DT), the VCT technology framework is continuously being enriched and refined. These diversified technologies continuously empower the entire lifecycle R&D of drugs and medical devices, with applications expanding and deepening across stages including drug discovery, preclinical research, and clinical trials, significantly enhancing R&D efficiency and reducing costs. The regulatory framework has been further refined, standards such as model credibility assessment are being gradually established, and the application of computer models and AI-generated virtual evidence in product evaluation and approval is receiving increasing attention. Despite existing challenges related to data foundations, model interpretability, regulatory standards, and technology translation, future advancements will rely on the integrated verification of multi-scale models, the construction of standardized data ecosystems, and the coordinated promotion of global regulatory harmonization. VCTs are expected to profoundly empower the transformation and upgrading of biomedical R&D.
JIN et al. (Wed,) studied this question.