Infrastructure for Evaluation of Statistical Alerts Arising from Vaccine Safety Data Mining Activities in Mini-Sentinel

Project Title Infrastructure for Evaluation of Statistical Alerts Arising from Vaccine Safety Data Mining Activities in Mini-Sentinel
Date Posted
Friday, July 22, 2016
Status
Complete
Deliverables
Description

Methods project to: 

  1. Integrate a data freeze into the Tree Extraction and Analysis process for one TreeScan method 
  2. Develop a means by which limited, de-identified, patient-level case data associated with selected alerts could be retrieved from the Data Partner sites and 
  3. Create a reporting tool for FDA and Mini-Sentinel clinicians and investigators to use in reviewing the case data
Workgroup Leader(s)

David Cole BM; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA 

Workgroup Members

Meghan Baker MD, ScD; Grace Lee MD, MPH; Judith C. Maro PhD, MS; Inna Dashevsky MS; W. Katherine Yih PhD, MPH; Carolyn Balsbaugh MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Martin Kulldorff PhD; Division of Pharmacoepidemiology & Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

Estelle Russek-Cohen PhD; David Martin MD, MPH; Michael Nguyen MD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD