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.

Learning Objectives:

• Identify the role of Electronic Health Records (EHRs) in generating real-world evidence for chronic disease outcomes.
• Describe the steps of the pipeline that links EHR data with registry information for predicting disease recurrence.
• Discuss the application of EHR-based algorithms in predicting renal cell carcinoma recurrence risk.