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

Basic Details
Date Posted
Friday, December 22, 2017
Status
Complete
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.

Additional Details
FDA Center
CBER
Time Period
June 2006 - December 2014
Study Type
Protocol/Surveillance Plan
Assessment Type
Exploratory Analyses
Population / Cohort
Individuals 9-26 years of age
Data Sources
Sentinel Distributed Database (SDD)
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

Corresponding Author

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