The FDA/PhRMA Biostatistics, Data Management, and Scientific Programming Leaders Meeting was held at the FDA’s White Oak facility in April. One of the major themes for this workshop was “Statistical Issues in Using Disparate Data Sources (combined clinical data, electronic medical records and claims) to Inform Safety and Effectiveness to Regulators and Other Stakeholders.” Highlights from the presentations and discussions will be presented including a perspective on why the demand for comparative effectiveness research, the strengths and weaknesses of different data sources and different study designs (randomized and non-randomized), results and lessons from OMOP, and ideas for using Bayesian approaches to help.