Mini-Sentinel: Analytical Methods to Assess Robustness of Drug Safety Monitoring Results

Project Title Mini-Sentinel: Analytical Methods to Assess Robustness of Drug Safety Monitoring Results
Date Posted
Friday, September 4, 2015
Status
Complete
Deliverables
Description

The purpose of this project was to identify suitable methods for evaluating the robustness of findings from observational analyses of the safety of drugs using longitudinal healthcare databases. The intent is that these methods for assessing the robustness of findings will be integrated into the Sentinel routine analytic framework and made available for use in safety monitoring activities to support decision makers. 

The programming code referenced in this report has not been formally audited in accordance with the Mini-Sentinel Standard Operating Procedure for Quality Control of SAS Programs. Programming code for Mini-Sentinel methods projects does not typically undergo the same level of formal audit as is done for exposure-outcome assessments and tool development. The code used in this project will be provided upon request in the spirit of supporting the exploration and development of novel scientific and statistical methods using observational healthcare data. Questions about the code will be referred to a Mini-Sentinel contact at FDA.

Workgroup Leader(s)

Joshua J. Gagne, PharmD, ScD; Sebastian Schneeweiss, MD, ScD; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, MA

Workgroup Members

Patrick Archdeacon, MD; Carlos Bell, MPH; Aaron Niman; Azadeh Shoaibi, PhD, MS, MHS; Office of Medical Policy, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Sophia Axtman, BA; April Duddy, MS; Susan Forrow, BA; Lingling Li, PhD; Judith Maro, PhD, MS; Jim Marshall, MPH; Catherine Rogers, MPH; Department of Population Medicine, Harvard Pilgrim Healthcare Institute and Harvard Medical School, Boston, MA

Steven Bird, PharmD, PhD, MS; Katrina Mott, MHS; Rita Ouellet-Hellstrom, PhD, MPH; Simone Pinheiro, ScD, MSc; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Sascha Dublin, MD, PhD; Group Health Research Institute, Seattle, WA

James Floyd, MD, MS; University of Washington, Cardiovascular Health Research Unit and Department of Epidemiology, Seattle, WA 

Richard Forshee, PhD; Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Matt Fox, DSc, MPH; Department of Epidemiology, Boston University School of Public Health, Boston University, Boston, MA

Tobias Gerhard, PhD; Center for Health Services Research on Pharmacotherapy, Chronic Disease Management, and Outcomes, Institute for Health, Health Care Policy and Aging Research, Rutgers, The State University of New Jersey, New Brunswick, NJ and Department of Pharmacy Practice and Administration, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ

Robert Glynn, PhD, ScD; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, MA

Chandrasekar Gopalakrishnan, MD, MPH, CPH; John Jackson DSc; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, MA

Darren Jansen; Mark Levenson, PhD; Yun Lu, PhD, MS; Office of Biostatistics and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Tim Lash, DSc MPH; Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA

Todd Lee, PharmD, PhD; Department of Pharmacy Systems Outcomes and Policy, College of Pharmacy University of Illinois at Chicago, Chicago, IL

David McClure, PhD; Marshfield Epidemiology Research Center, Marshfield Clinic, Marshfield, WI

Michael Nguyen, MD; Sukhminder Sandhu, PhD, MPH, MS; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Marsha Reichman, PhD; Center for Drug Evaluation and Research, FDA, Silver Spring, MD

Dylan Small, PhD; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, PA

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