Toward widespread use of virtual trials in medical imaging innovation and regulatory science.

The rapid advancement in the field of medical imaging presents a challenge in keeping up to date with the necessary objective evaluations and optimizations for safe and effective use in clinical settings. These evaluations are traditionally done using clinical imaging trials, which while effective, pose several limitations including high costs, ethical considerations for repetitive experiments, time constraints, and lack of ground truth. To tackle these issues, virtual trials (aka in silico trials) have emerged as a promising alternative, using computational models of human subjects and imaging devices, and observer models/analysis to carry out experiments. To facilitate the widespread use of virtual trials within the medical imaging research community, a major need is to establish a common consensus framework that all can use. Based on the ongoing efforts of an AAPM Task Group (TG387), this article provides a comprehensive overview of the requirements for establishing virtual imaging trial frameworks, paving the way toward their widespread use within the medical imaging research community. These requirements include credibility, reproducibility, and accessibility. Credibility assessment involves verification, validation, uncertainty quantification, and sensitivity analysis, ensuring the accuracy and realism of computational models. A proper credibility assessment requires a clear context of use and the questions that the study is intended to objectively answer. For reproducibility and accessibility, this article highlights the need for detailed documentation, user-friendly software packages, and standard input/output formats. Challenges in data and software sharing, including proprietary data and inconsistent file formats, are discussed. Recommended solutions to enhance accessibility include containerized environments and data-sharing hubs, along with following standards such as CDISC (Clinical Data Interchange Standards Consortium). By addressing challenges associated with credibility, reproducibility, and accessibility, virtual imaging trials can be positioned as a powerful and inclusive resource, advancing medical imaging innovation and regulatory science.