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

Project Title Developments, Applications, and Methodological Challenges to the use of Propensity Score Matching Approaches in FDA’s Sentinel Program
Date Posted
Tuesday, October 4, 2016
Status
Complete
Deliverables
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.

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 Members

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