Judith Maro is an Associate Professor in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She received her doctorate in Engineering Systems at the Massachusetts Institute of Technology (MIT). Dr. Maro's main research interest is implementation of pharmacovigilance techniques, particularly continuous near-real time sequential statistical analysis methods and data-mining / signal identification methods in distributed longitudinal databases. She is a site principal investigator for the U.S. Centers for Disease Control and Prevention’s Vaccine Safety Datalink and also the Operations Lead for the Sentinel Operations Center as part of the U.S. Food and Drug Administration’s Sentinel System.
For many years, real-world data — e.g., administrative claims and electronic health records — have played a critical role in medical product safety through traditional Post-Approval Safety Studies. With advances in real-world data availability, methods, and tools, real-world evidence is increasingly being used as part of routine pharmacovigilance activities in the signal management process. While less well established, there is growing interest in using secondary real-world data for signal detection to identify new safety observations. Covering multiple stakeholder perspectives, this panel will discuss the current state and future potential of real-world data in signal detection