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Developments, Applications, and Methodological Challenges to the Use of Propensity Score Matching Approaches in FDA’s Sentinel Program

Basic Details
Date Posted
Status
Complete
Description

Since 2013, the Sentinel program has been evaluating and using the PSM tool to assess the safety of various drugs. As part of the development and enhancement process, the tool has also been used to replicate known associations in the Sentinel Distributed Database. The purpose of this report is to describe the development, application, and performance of PS-based approaches used in Sentinel, with a particular focus on the challenges and successes of these approaches in the distributed analysis setting.

Deliverable(s) (1)
Developments, Applications, and Methodological Challenges to the use of Propensity Score Matching Approaches in FDA’s Sentinel Program
Related Links
Related Link(s)
2016 ICPE Poster: Developments, Applications, and Methodological Challenges to the Use of Propensity Score Matching Approaches in FDA's Sentinel Program
Workgroup Leader(s)

John G. Connolly, SM; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

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

Workgroup Member(s)

Joshua J. Gagne, PharmD, ScD; Shirley V. Wang, PhD; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

Noelle Cocoros, DSc, MPH; Candace C. Fuller, PhD; Hannah Katcoff, MPH; Catherine A. Panozzo, PhD; Sengwee Toh, ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Xu Han, PhD; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA

Meijia Zhou, MHS; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA and Center for Pharmacoepidemiology Research and Training, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA