Empowering Electronic Health Records to Uncover Real World Evidence in Chronic Disease Progression: A Case Study of Renal Cell Carcinoma Recurrence Risk Prediction

The 21st Century Cures Act, along with the FDA's Real-World Evidence (RWE) framework, has established a foundation for incorporating real-world data (RWD) into regulatory decision-making processes. Among the various sources of RWD, Electronic Health Records (EHRs) have emerged as a crucial asset, providing rich insights into treatment responses across diverse patient populations in real-world settings. These insights are essential for generating robust and meaningful RWE. In this presentation, I will introduce a comprehensive pipeline for generating reproducible and generalizable real-world evidence (RWE) on longitudinal disease outcomes by leveraging electronic health record (EHR) data. The pipeline links EHR data with registry information and uses algorithms based on longitudinal EHR features to evaluate the outcomes for chronic diseases. The practical application of this pipeline will be illustrated through a case study focused on predicting the risk of renal cell carcinoma (RCC) recurrence.