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

Basic Details
Date Posted
Status
Complete
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
Deliverable(s) (1)
Infrastructure for Evaluation of Statistical Alerts Arising from Vaccine Safety Data Mining Activities in Mini-Sentinel Report
Workgroup Leader(s)

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

Workgroup Member(s)

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