Our Real-World Evidence Practice leads both applied and methodologic research on the safety, effectiveness, and utilization of drugs and vaccines using large healthcare data sources and multi-site research collaborations.
Our Mission is to provide quality pharmacoepidemiology research for industry collaborators to advance public health research. Our Vision is to expand the work we do within pharmacoepidemiology and work with new funders. We are collaborators. We bring our scientific knowledge and our longstanding relationships to work with pharmaceutical sponsors to generate the highest quality real world evidence.
Our work in pharmacoepidemiology and real-world evidence spans nearly four decades and has helped shape the development of modern distributed health data networks.
Investigators in our group began collaborating with the U.S. Food and Drug Administration (FDA) in the mid-1980s through research programs supporting epidemiologic investigations of safety concerns related to marketed drugs and evaluations of risk-management strategies. These efforts helped establish early approaches for conducting post-marketing drug safety and utilization studies using large healthcare data sources.
During the late 1990s and early 2000s, researchers at the Institute played a central role in developing multi-institutional research networks to study the safety and effectiveness of therapeutics across large populations. This work included collaborations within the Health Care Systems Research Network and leadership of an Agency for Healthcare Research and Quality Center for Education and Research on Therapeutics, helping to establish the infrastructure for distributed data network research.
In 2000, the Institute joined the Centers for Disease Control’s Vaccine Safety Datalink (VSD), contributing to ongoing national efforts to monitor vaccine safety using large, linked healthcare datasets. As part of the VSD our investigators led the development of near real time surveillance for adverse effects of newly introduced products, as well as the development of tree-based scan statistics for detecting signals of unspecified adverse effects.
In 2009, we were awarded the contract to establish the Coordinating Center for the Sentinel Initiative, a national distributed data network developed by the FDA to actively monitor the safety of FDA-regulated medical products. The program began as the Mini-Sentinel pilot and evolved into the full Sentinel System in 2014. Sentinel became a benchmark system globally for active medical product safety surveillance.
In parallel with these infrastructure efforts, we contributed to the development of key pharmacoepidemiologic methods, including approaches for distributed data network analytics, sequential safety surveillance, signal detection, and the use of large healthcare databases to study medication safety and effectiveness. Our research has also contributed to foundational work on medication safety during pregnancy and the evaluation of vaccines and therapeutics in real-world populations.
We work with life sciences organizations to design and conduct rigorous pharmacoepidemiologic studies addressing regulatory commitments, safety surveillance, comparative effectiveness, validation, and real-world utilization of medical products.
