With the widespread adoption of electronic health records (EHRs) and the push within the FDA to use real-world data in clinical trials, there is an opportunity to leverage these sources of data to monitor patients after a clinical trial ends. New technology makes it possible to add new approaches to post-marketing surveillance. This course is designed to provide an introduction and overview of patient-safety monitoring post-clinical trials and insight into how electronic health data can be used to support post-marketing surveillance. The course will start with an overview of the current approaches that the FDA uses to monitor drug and device safety through standards-based reporting, traditional safety studies, disease and device-specific registries and other safety monitoring programs (such as AHRQ safety reporting) to assess patient safety.

The second portion of the course will explore how new technology and standards such as privacy-preserving record linkage (PPRL linkage), active surveillance and clinical trial data handling strategies can improve both current, and future assessments of patient safety. The hope is that by understanding these new approaches, and anticipating how they can be used to support post-marketing surveillance, participants will be able to develop a real-world data strategy that can reduce cost and burden for safety monitoring and research. Ultimately, these initiatives will be building blocks in developing a learning health system, where each interaction that a patient or clinical trials participant has with the health system generates real-world data suitable for patient safety monitoring and post-marketing surveillance.

This course is designed for those with limited experience in the area of utilizing real-world evidence to support patient safety or for those who want more information and experience.