ABSTRACT
The drug safety profile prior to approval is largely determined through the evaluation of safety data obtained from clinical trials. Although often considered not as rigorous as inference from clinical trials, causal inference based on observational studies is sometimes the only feasible or timely option post-marketing. While these methods and examples are specific to the FDA-conducted studies, the same principles and methods apply when the FDA requests studies from pharmaceutical industry or evaluates evidence from the literature. The Sentinel system is a large network of healthcare databases, built by the FDA for drug safety surveillance. The Sentinel system has existed for more than a decade. It started with the passing of the Food and Drug Administration Amendments Act by the United States Congress in 2007. The founders of the Sentinel system recognized early on that the best way to leverage data from multiple sources in a timely way is to standardize the data sources.
