FDA's Sentinel Initiative - Background
At a time when patients and caregivers are demanding more information about the associated benefits and potential risks of the medical products they use, 21st century technology has opened up innovative methods of actively monitoring FDA-regulated products to enhance public safety in ways previously unachievable.
In the fall of 2007, Congress passed the FDA Amendments Act (FDAAA), mandating the FDA to establish an Active Postmarket Risk Identification and Analysis (ARIA). FDAAA requires the FDA to develop, in collaboration with public, academic, and private entities, methods to obtain access to disparate data sources and validated methods for the establishment of a system to link and analyze safety data from multiple sources. In May 2008, the FDA launched the Sentinel Initiative to create a national electronic system, the Sentinel System, for medical product safety surveillance.
The first phase of this initiative was the Mini-Sentinel Pilot to inform the development of the Sentinel System. In September 2014, the FDA began transitioning from the Mini-Sentinel phase to the full Sentinel System, which officially launched in February 2016. We will continue to expand access to new data types and develop analytic methods to enhance our safety surveillance capabilities and allow the Agency to rapidly address the variety of safety questions that may come up in the future. The way the Agency uses Sentinel will continue to grow over time.
The FDA has long used administrative and insurance claims databases to investigate safety questions about Agency-regulated products, but until Sentinel, the Agency generally was only able to work with one particular healthcare system at a time to evaluate a given safety issue.
Sentinel has the largest multisite distributed database in the world dedicated to medical product safety. It is constantly growing and improving to meet FDA’s needs. Descriptive statistics on the Sentinel database can be found on the Sentinel webpage. The active surveillance capability of the Sentinel System does not replace the FDA’s existing surveillance tools, but complements other FDA safety surveillance capabilities by allowing the FDA to proactively assess the safety of regulated medical products.
The FDA continues to develop Sentinel in stages to ensure the development of a long-term, sustainable system. For this reason, we are committed to engaging stakeholders to ensure issues of great public interest, such as governance, privacy, data standards and public availability of results are addressed.
Sentinel System Five-Year Strategy: 2019-2023
To lay out the major goals associated with the future of the Sentinel System and FDA Catalyst, the FDA is issuing the “Sentinel System Five-Year Strategy: 2019-2023.” This plan is intended to serve as a roadmap to guide the development of the Sentinel System between 2019 and 2023. Specifically, the plan discusses five strategic aims. First, enhance and expand the Sentinel System’s foundation (i.e. data, infrastructure, operations, technology). Second, augment the Sentinel System’s safety analysis capabilities by leveraging advances in data sciences and signal detection. Third, leverage the Sentinel System to accelerate access to and broader use of Real-World Data (RWD) for Real-World Evidence (RWE) generation. Fourth, broaden the Sentinel System’s ecosystem of stakeholders to pursue the vision of a national resource. Finally, disseminate knowledge and advance regulatory science to encourage innovation and meet Agency scientific needs.
- Report to Congress 8/19/11
- The Sentinel Initiative July 2010 Report
- FDA's Sentinel Initiative - Background
- The Sentinel Initiative May 2008 Report
- Sentinel Video
- Mini-Sentinel Supplement on Pharmacoepidemiology and Drug Safety (PDS) (January 2012)
- PDUFA V Sentinel Program Interim (2015) and Final (2017) Assessments