FDA has been promoting enrollment practices that could enhance the diversity of clinical trial populations, through broadening eligibility criteria. However, how to broaden eligibility remains a significant challenge. We propose an AI approach to Cohort Optimization (AICO) through transformer-based natural language processing of the eligibility criteria and evaluation of the criteria using real-world data. The method can extract common eligibility criteria variables from a large set of relevant trials and measure the generalizability of trial designs to real-world patients. It overcomes the scalability limits of existing manual methods and enables rapid simulation of eligibility criteria design for a disease of interest. A case study on breast cancer trial design demonstrates the utility of the method in improving trial generalizability.

使用基于Transformer的自然语言处理的人工智能方法(AICO)，通过真实数据评估入组标准，从大量相关临床试验中提取常见入组标准变量并测量临床试验设计的泛化性，解决了现有手动方法的可扩展性问题，并能快速模拟感兴趣疾病的入组标准设计。以乳腺癌试验设计为例，展示了该方法在改进临床试验泛化性方面的效用。

一种可扩展的临床试验队列优化的AI方法