Analytical Methods to Assess Robustness of Drug Safety Monitoring Results

Project Title 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