Quantitative Bias Analysis Methodology Development

Project Title Quantitative Bias Analysis Methodology Development
Date Posted
Friday, August 4, 2017
Status
Complete
Deliverables
Description

The purpose of this project is to develop an approach to using quantitative bias analysis methods to adaptively determine whether and when medical chart validation can be stopped early within the context of Sentinel assessments.

The newly developed approach will be applied to one or more completed Sentinel assessments in which medical record review for outcome validation was performed to test the empirical and practical performance of the method.

Workgroup Leader(s)

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

Noelle Cocoros DSc, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Yun Lu PhD, MS; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Workgroup Members

Sandra Feibelmann MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

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

Chandrasekar Gopalakrishnan MD, MPH, CPH; Martin Kulldorff PhD; Sebastian Schneeweiss MD, ScD; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

Christopher Jankosky MD; Yun Lu PhD, MS; Azadeh Shoaibi PhD, MS, MHS; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

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