Keywords: Safety, Controlled Studies, Observational Studies, Real World Evidence
Safety evaluation is a continual and iterative process which requires thorough thinking. It often requires long time horizons and large amounts of data to fully understand the safety profile of a medical product. While clinical trials provide high-quality data for an initial assessment of the safety profile of a new drug, they alone cannot fully characterize the safety profile. Thus, post-marketing observational methods and real-world data sources play a critical role in further understanding the safety profile of a drug. Clinical trial data and real world data are part of a continuum of evidence for safety decision making. Along with randomized controlled trials (RCTs), regulatory agencies are increasingly integrating such database analyses into their decision making for drug approval and monitoring of unintended harm. In this presentation, we will present multi-source safety data and the continuum safety evidence. We will outline some analysis methods for RCT and RWD evidence integration.