To lay out the major goals associated with the future of the Sentinel System and FDA Catalyst, the FDA has released the Sentinel System Five-Year Strategy: 2019-2023. This plan is intended to serve as a roadmap to guide the development of the Sentinel System between 2019 and 2023.
In this article, FDA Commissioner Scott Gottlieb and Office of Surveillance and Epidemiology Director Gerald Dal Pan describe how Sentinel has become an integral part of FDA's safety monitoring efforts and announce new steps that the Agency is taking to make Sentinel more robust.
This report had two goals: 1) to compare the baseline characteristics of ranolazine and beta blockers users and 2) to utilize a self-controlled risk interval study design to estimate the risk of seizure events within specified risk and control windows for ranolazine users, and those with concomitant use of ranolazine and CYP3 inhibitors.
The Sentinel Data Quality Review and Characterization Programs are used by the Sentinel Operations Center (SOC) for data quality review and characterization of the Sentinel Distributed Database (SDD).
This project focused on developing a stable, feasible approach to enable secure distributed linear, logistic, and Cox regression analysis within a distributed data network while not requiring sharing of any patient-level datasets from the participating data partners.
Authored by Sentinel and FDA investigators, this Perspective reviews Sentinel's evolution into a flexible and robust program that provides evidence on the effects of medical products while protecting patient privacy. It also notes Sentinel's role in supporting FDA's plans to use Real World Evidence, and describes the program's progress in becoming a cornerstone of a learning health care system.
Sentinel routine querying tools are SAS programs designed to run against the Sentinel Common Data Model (SCDM). They allow rapid implementation of standard queries across the Sentinel Distributed Database (SDD). The programs can be customized using various input parameters that define medical product exposures, outcomes, covariates, diagnoses, date ranges, age ranges, and other implementation details. Tools can perform simple cohort characterization and descriptive analyses, but may also be used to perform more complex adjustment for confounding and support prospective surveillance activities.
The Cohort Identification and Descriptive Analysis (CIDA) program is the foundation of the routine querying system. CIDA is responsible for identifying, extracting, and characterizing cohorts of interest from the SDD based on the specification of a number of requester-defined options (e.g., continuous enrollment requirements, incidence criteria, inclusion/exclusion criteria).
The Sentinel Operations Center (SOC) coordinates the network of Sentinel Data Partners and leads development of the Sentinel Common Data Model (SCDM), a standard data structure that allows Data Partners to quickly execute distributed programs against local data.
Changes in this release from v6.0.2 to v7.0.0 include a new Mother-Infant Linkage table and are listed in the “History of Modifications” tab of the SCDM v7.0.0 document.
Sentinel Initiative Public Workshop
The Eleventh Annual Sentinel Initiative Public Workshop will be held on Wednesday, April 3, 2019. Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this annual workshop serves as a forum to bring together leading experts and interested stakeholders to discuss the ongoing development of the Sentinel Initiative.
Public Sentinel Training at FDA
The 2019 Sentinel Public Training, Day 2 of the Eleventh Annual Sentinel Initiative Public Workshop will be held on April 4, 2019. The Training will focus on enabling expanded use of Sentinel tools among the public and will consist of a series of presentations and exercises on the Cohort Identification and Descriptive Analysis (CIDA) tool.
International Regulator’s Forum
The U.S. Food and Drug Administration (FDA) will be hosting a forum on April 5, 2019 on the Sentinel System for other regulatory agencies immediately following the two-day Sentinel Annual Meeting. This is a forum designed for staff from regulatory agencies worldwide: it is a meeting by regulators, for fellow regulators.
The Sentinel Operations Center (SOC) has transformed the Medicare Claims Synthetic Public Use Files (SynPUFs) into the Sentinel Common Data Model (SCDM) format as part of an ongoing effort to make Sentinel resources available to external investigators, with the goal of creating a community of investigators who can understand, utilize, and contribute to the Sentinel enterprise.