Randomized clinical trials, while often viewed as the highest evidentiary bar
by which to judge the quality of a medical intervention, are far from perfect.
In silico imaging trials are computational studies that seek to ascertain the
performance of a medical device by collecting this information entirely via
computer simulations. The benefits of in silico trials for evaluating new
technology include significant resource and time savings, minimization of
subject risk, the ability to study devices that are not achievable in the
physical world, allow for the rapid and effective investigation of new
technologies and ensure representation from all relevant subgroups. To conduct
in silico trials, digital representations of humans are needed. We review the
latest developments in methods and tools for obtaining digital humans for in
silico imaging studies. First, we introduce terminology and a classification of
digital human models. Second, we survey available methodologies for generating
digital humans with healthy and diseased status and examine briefly the role of
augmentation methods. Finally, we discuss the trade-offs of four approaches for
sampling digital cohorts and the associated potential for study bias with
selecting specific patient distributions.

通过计算机模拟收集信息对医疗设备性能进行评估的计算研究在评估新技术方面具有显著的资源和时间节约优势，需要数字化人体模型来进行，本文回顾了获取数字人体的最新方法和工具的发展。

随机数字人现已开始招募进行体外成像试验 —— 生成数字队列的方法和工具

The stochastic digital human is now enrolling for in silico imaging trials -- Methods and tools for generating digital cohorts

A clinical trial is an essential step in drug development, which is often
costly and time-consuming. In silico trials are clinical trials conducted
digitally through simulation and modeling as an alternative to traditional
clinical trials. AI-enabled in silico trials can increase the case group size
by creating virtual cohorts as controls. In addition, it also enables
automation and optimization of trial design and predicts the trial success
rate. This article systematically reviews papers under three main topics:
clinical simulation, individualized predictive modeling, and computer-aided
trial design. We focus on how machine learning (ML) may be applied in these
applications. In particular, we present the machine learning problem
formulation and available data sources for each task. We end with discussing
the challenges and opportunities of AI for in silico trials in real-world
applications.

本文系统综述了三个主要主题：临床模拟，个体化预测建模和计算机辅助试验设计，重点关注机器学习在这些应用中的应用，讨论了 AI 在实际应用中 in silico 试验的挑战和机遇。