ARIA is a component of FDA’s Sentinel System that is used to conduct medical product safety surveillance. ARIA consists of:
- Pre-defined, parameterized, reusable routine querying tools
- The electronic data in the Sentinel Common Data Model
Active Risk Identification and Analyses Conducted Since 2016
This graphic displays the total number of analyses conducted by FDA in ARIA since its launch in 2016. There are several types of analyses, including:
- Summary table analyses (retired in September 2019)
- Query Builder analyses
- Level 1 analyses
- Level 2 analyses
More technical information on these analyses are on the Routine Querying Tools section. Results from these analyses are on the Assessments page, as they become available. Key regulatory outcomes for these analyses are on Completed ARIA Assessments & Impact.
Want to learn more about ARIA? Read about technical details of all Sentinel’s analytic tools that support ARIA.
Levels of Safety Analyses
ARIA uses parameterizable tools and a trusted multi-site distributed database. The data undergoes continuous quality checks and refreshes. With ARIA, safety analyses are conducted more efficiently—in a matter of months, rather than years. It also fulfills the mandate in the FDA Amendments Act of 2007.
FDA uses ARIA to conduct several types of analyses to monitor the safety of FDA approved medical products.
Level 1: Descriptive Analyses, Unadjusted Rates
Level 1 analyses characterize patterns of use of prescription medications or calculate rates of health outcomes of interest. The Sentinel Query Builder application represents a subset of Level 1 functionality. Query Builder analyses are typically run on IBM® MarketScan® Research Databases but some are also run on Sentinel's distributed database.
Levels 2 and 3: Adjusted Analyses with Sophisticated Confounding Control
Level 2 and 3 analyses are used to study whether an adverse effect is potentially related to a drug. It also estimates the size of that risk, if one is identified.
Signal Identification
ARIA can also be used to detect new and unsuspected potential safety concerns.
FDA uses ARIA to study signals that come from many sources, such as the FDA Adverse Event Reporting System (FAERS), observational studies, or clinical trials. To learn more, please refer to FDA’s Best Practices for Postmarket Safety Surveillance document.
With ARIA, safety analyses are more efficient. ARIA also fulfills the mandate in the FDA Amendments Act of 2007.
