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Curr Epidemiol Rep. 2017 Dec;4(4):298-306. doi: 10.1007/s40471-017-0121-0. Epub 2017 Oct 6.

Development and application of two semi-automated tools for targeted medical product surveillance in a distributed data network.

Author information

1
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School Boston, MA.
2
Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA.
3
Center for Clinical Epidemiology and Biostatistics, Pereleman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
4
Center for Pharmacoepidemiology Research and Training, University of Pennsylvania Pereleman School of Medicine, Philadelphia, PA.

Abstract

Purpose of Review:

An important component of the Food and Drug Administration's Sentinel Initiative is the active post-market risk identification and analysis (ARIA) system, which utilizes semi-automated, parameterized computer programs to implement propensity-score adjusted and self-controlled risk interval designs to conduct targeted surveillance of medical products in the Sentinel Distributed Database. In this manuscript, we review literature relevant to the development of these programs and describe their application within the Sentinel Initiative.

Recent Findings:

These quality-checked and publicly available tools have been successfully used to conduct rapid, replicable, and targeted safety analyses of several medical products. In addition to speed and reproducibility, use of semi-automated tools allows investigators to focus on decisions regarding key methodological parameters. We also identified challenges associated with the use of these methods in distributed and prospective datasets like the Sentinel Distributed Database, namely uncertainty regarding the optimal approach to estimating propensity scores in dynamic data among data partners of heterogeneous size.

Summary:

Future research should focus on the methodological challenges raised by these applications as well as developing new modular programs for targeted surveillance of medical products.

KEYWORDS:

ARIA; Sentinel; drug safety; pharmacoepidemiology; surveillance; targeted

Conflict of interest statement

Conflict of Interest John G. Connolly, Catherine A. Panozzo, Noelle Cocoros, Meijia Zhou, and Judith C. Maro each declare no potential conflicts of interest. Sengwee Toh reports grants from U.S. Food and Drug Administration during the conduct of the study. Shirley V. Wang reports grants from Sentinel Initiative, during the conduct of the study; personal fees from Aetion, Inc., grants from Novartis, grants from Agency for Healthcare Research and Quality outside the submitted work. Joshua J. Gagne reports grants from US FDA, during the conduct of the study; grants from Novartis Pharmaceuticals Corporation, grants from Eli Lilly and Company, personal fees from Aetion, Inc, personal fees from Optum, Inc., outside the submitted work. Candace C. Fuller reports grants from U.S. Food and Drug Administration during the conduct of the study.

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