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Six Years of FDA's Postmarket Active Risk Identification and Analysis System (ARIA) in the Sentinel Initiative: Implications for Real World Evidence Generation

    Basic Details

    Congress mandated the creation of a postmarket active risk identification and analysis (ARIA) system containing data on 100 million individuals for monitoring risks associated with drug and biologic products using data from disparate sources to complement the US Food and Drug Administration's (FDA's) existing postmarket capabilities. We report on the first six years of ARIA utilization in the Sentinel System (2016 -2021). The FDA has used the ARIA system to evaluate 133 safety concerns; 54 of these evaluations have closed with regulatory determinations, while the rest remain in progress. 


    Judith C Maro, Michael D Nguyen, Joy Kolonoski, Ryan Schoeplein, Ting-Ying Huang, Sarah K Dutcher, Gerald J Dal Pan, Robert Ball

    Corresponding Author

    Judith C Maro; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA