About the Real-World Evidence Practice

Our investigators began collaborating with the U.S. Food and Drug Administration (FDA) in the mid-1980s, supporting early efforts to evaluate drug safety and risk management strategies using large healthcare data sources.

These efforts helped establish foundational approaches to:

• Post-marketing safety evaluation
• Use of healthcare databases for epidemiologic research
• Risk management and surveillance strategies

During this period, our researchers played a central role in developing multi-institutional research networks to study the safety and effectiveness of therapeutics across large populations.

This work included:

• Leadership in national research collaborations
• Development of infrastructure for distributed data network studies
• Contributions to the CDC Vaccine Safety Datalink (VSD)

Our research supported:

• Near real-time safety surveillance
• Signal detection for emerging adverse events
• Development of tree-based scan statistics

In 2009, we established the Coordinating Center for the Sentinel Initiative, a national distributed data network developed by the FDA to actively monitor the safety of regulated medical products.

Through our stewardship, the program:

• Began as the Mini-Sentinel pilot
• Evolved into the full Sentinel System in 2014
• Remains a benchmark system for active medical product safety surveillance

In parallel, our work has advanced:

• Methods for distributed data network analyses
• Safety and effectiveness studies using large healthcare databases
• Research on medication safety during pregnancy
• Evaluation of vaccines and therapeutics in real-world populations