Postlicensure Medical Product Safety Data-Mining: Power Calculations for Bernoulli Data

Project Title Postlicensure Medical Product Safety Data-Mining: Power Calculations for Bernoulli Data
Date Posted
Friday, December 22, 2017
Status
Complete
Deliverables
Related Links
Description

This project build upon TreeScan Power Evaluation activity funded under the PRISM 2013 task order that is developing software to enable power calculations for the tree-based scan statistic. This extension activity enhanced the TreeScan software to perform power evaluation for the tree-temporal scan statistic as well as evaluate the power for the tree-temporal scan statistic when used for adolescent vaccines, considering different sample sizes, adverse event outcomes, and relative risks.

Population / Cohort
Individuals 9-26 years of age
Time Period
June 2006 - December 2014
Assessment Type
Exploratory Analyses
Study Type
Protocol/Surveillance Plan
Workgroup Leader(s)

Judith C. Maro PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston MA

Workgroup Members

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

Inna Dashevsky MS; Meghan Baker MD, ScD; Claudia Coronel-Moreno MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston MA

Steven Anderson PhD, MPP; Azadeh Shoaibi PhD, MHS, MS; Rositsa Dimova MS, PhD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Estelle Russek-Cohen PhD; Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CBER
Corresponding Author

Judith C. Maro, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA. Email: jmaro@mit.edu