The primary tool used by the FDA for drug post-market safety surveillance is the Sentinel System. This system, authorized in 2007 in the FDA Amendments Act, started with a pilot in 2009 and as of 2016 is a fully operational tool for linking and analyzing safety data from multiple sources. The system includes the capability to assess risk using real-world data (RWD) through its Active Post-market Risk Identification and Analysis (ARIA) capability. The Sentinel System is now the core of the agency’s post-market safety surveillance process.

In January the agency issued a 5 year strategy plan for further development of the Sentinel System. These goals are:

• enhance and expand the Sentinel System’s data, infrastructure, operations and technology; 
• use advances in data science and signal detection to improve its safety analysis capabilities; 
• accelerate access to and broaden the use of RWD for real-world evidence (RWE) through the System; 
• expand the ecosystem of stakeholders to make the System a national resource; and
• disseminate knowledge and advance regulatory science to encourage additional innovation and meet the Agency’s scientific needs.

While the last point sounds a bit nebulous, the other 4 are concepts that should excite patients, physicians, researchers, and sponsors. Improved public access to global safety surveillance data could lead to a identifying issues sooner, better fundamental research and detection of emerging safety issues, and innovative tools for detection, reporting, and distribution of critical safety alerts.

Readers interesting in participating in this initiative should consider attending the public workshop (which will include training on the Sentinel System) scheduled for 03APR2019. Read more about the initiative and its projects at the Sentinel System web page.

Text Copyright © 2019 Katrina Rogers