Statistical challenges in systematic evidence generation through analysis of observational healthcare data networks.

Observational healthcare databases offer significant potential for generating evidence about the effects of medical products. Recent US and international efforts attempt to coordinate analysis activities across observational data networks for active drug safety surveillance and comparative effectiveness research. Several statistical challenges exist that require further research to inform the appropriate use of observational data for identifying and evaluating temporal relationships between medical product exposures and outcomes. This review highlights current work across the areas of data quality, methods development, and performance evaluation that promise to contribute to our understanding of best practices for observational analyses moving forward.