As the US Food and Drug Administration's (FDA) Sentinel Initiative approaches its 11th
anniversary, the agency on Wednesday laid out its vision for enhancing the system over the next five years.
First launched as a pilot program in 2008, the Sentinel Initiative encompasses FDA’s effort to meet obligations set by Congress in the 2007 Food and Drug Administration Amendments Act
to develop a system for active postmarket risk identification and analysis for medical products.
Since then, the agency has agreed to further expand Sentinel's capabilities as part of its Prescription Drug User Fee Amendments
(PDUFA VI) commitments.
By 2016, Sentinel transitioned
from its "Mini-Sentinel" pilot phase to a fully operational system that the Center for Drug Evaluation and Research (CDER) Director Janet Woodcock called an "integral part of routine safety surveillance."
Now, two years later, FDA says it plans to enhance Sentinel by focusing on emerging technologies and innovations in data science over the next five years, including natural language processing, advanced analytics, new data sources and improved data interoperability.
"Maximizing the benefits of today's sophisticated arsenal of FDA-approved medical products requires an equally advanced set of tools for collecting this data, and evaluating it, as a way to monitor and inform about the safety of these new innovations," write FDA Commissioner Scott Gottlieb and Gerald Dal Pan, Director of the Office of Surveillance and Epidemiology at the CDER.
To do so, FDA has set five strategic goals it aims to achieve over the next five years:
- "Enhance and expand the Sentinel System's foundation, including data, infrastructure, operations and technology;
- Augment Sentinel's safety analysis capabilities using advances in data science and signal detection;
- Use the Sentinel System to accelerate access to and broaden the use of real world data for real world evidence;
- Broaden the Sentinel System's ecosystem of stakeholders to pursue the vision of a national resource; and
- Disseminate knowledge and advance regulatory science to encourage innovation and meet the agency's scientific needs."
Within the five-year strategy, FDA also lays out some of the near-, mid- and long-term activities it will carry out to support those goals.
Some of those activities include improving on mother-infant linkages; increasing the number of validated health outcomes of interest (HOIs); developing electronic health record validation methods; improving on signal detection capabilities; and building on Sentinel's abilities to measure effectiveness using real world data (RWD).
FDA will also be presenting its plans for enhancing Sentinel at an upcoming two-day public workshop
, Sentinel System Five-Year Strategy 2019-2023