Six Years of the US Food and Drug Administration's Postmarket Active Risk Identification and Analysis System in the Sentinel Initiative: Implications for Real World Evidence Generation

• DOI: 10.1002/cpt.2979
• Publication Date: 2023-07-01T02:47:03Z
• Authors: Judith C. Maro; Michael D. Nguyen; Joy Kolonoski; Ryan Schoeplein; Ting‐Ying Huang; Sarah K. Dutcher; Gerald J. Dal Pan; Robert Ball
• Keywords: Identification

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 biologic products using from disparate sources to complement US Food Drug Administration's (FDA's) existing capabilities. We report first 6 years ARIA utilization in Sentinel System (2016-2021). The FDA has used evaluate 133 safety concerns; 54 these evaluations have closed regulatory determinations, whereas rest remain progress. If FDA's Adverse Event Reporting are deemed insufficient address concern, then may issue requirement product's manufacturer. One hundred ninety-seven insufficiency determinations been made. most common situation which was found be is evaluation adverse pregnancy fetal outcomes following utero exposure, followed by neoplasms death. likely sufficient thromboembolic events, high positive predictive value claims alone do not require supplemental clinical data. lessons learned this experience illustrate continued challenges administrative data, especially define novel outcomes. This analysis can help identify where more granular needed fill gaps improve use real-world analyses provide insights into what efficiently generate high-quality evidence efficacy.