FDA Updates Sentinel Initiative Status

In a presentation published on FDA’s website on March 15, 2012, Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, outlined the current status and future plans for FDA’s Sentinel Initiative, an electronic drug-safety tracking system established as part of the FDA Amendments Act of 2007.

Woodcock’s presentation outlined Mini-Sentinel, a pilot project developed to inform and facilitate development of the Sentinel System for monitoring the safety of FDA-regulated medical products. Collaborators in Mini-Sentinel include data and academic partners that provide access to healthcare data and ongoing scientific, technical, methodological, and organizational expertise.

Mini-Sentinel includes a coordinating center that can access automated healthcare data systems to develop and evaluation scientific methodologies that might be used in the fully operational Sentinel System. The pilot program would also provide FDA with the opportunity to investigate safety issues in existing data systems.

The presentation also featured an update on other plans in development, including a framework to refine safety signals in “near real time” and plans to incorporate registries and other data sources to match nonpersonally identifiable data.

Also featured in the presentation was the Observational Medical Outcomes Partnership (OMOP) project, which includes an active surveillance community and a research experiment to test various methods for detecting associations between drugs and medical outcomes and characterizing datasets and investigation of the impact of multiple “parameter settings” for each method.

Future plans for the Sentinel Initiative include expansion of data sources through Mini-Sentinel, continued research, and ongoing data utilization. FDA envisions a public-private partnership that would “allow other parties to participate in research and studies using Sentinel infrastructure.” FDA also hopes for a future national secondary use data resource for research, according to the presentation.

The Sentinel Initiative was established to create a postmarket risk identification and analysis system to link and analyze safety data from multiple sources, including federal health-related electronic data and private-sector electronic health data. By linking the data, FDA hopes to identify and evaluate safety issues “in near real time.” The Initiative will also give FDA access to longer-term data and expand access to advents not normally reported to FDA.