Title: From Quantitative Drug Safety to Real-World Evidence: Activities at the US FDA
Abstract: In the last decade, the US FDA has initiated numerous efforts to continue to improve its evaluations of drug safety both in the premarket and post-market realms. These efforts have entailed making use of novel data sources and novel statistical designs and analyses. Recently there has been increased discussion of making additional use of novel data sources to provide evidence of efficacy, an area known as real-world evidence. This talk will review the FDA drug safety efforts and provide some illustrative examples. The address will then explore the present state and potential of the use of real-world evidence. Additionally, the talk will briefly summarize other efforts in the Office of Biostatistics to support drug regulation.