TreeScan Power (PRISM)

Project Title TreeScan Power (PRISM)
Date Posted
Thursday, November 13, 2014
Status
In progress
Description

Methods project to develop a planning procedure to optimize the use of the Tree-Based Scan Statistic for newly licensed vaccines and reports related to Title IX, section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which requires that postmarket evaluations are performed 18 months after approval of the drug or after it is used by 10,000 individuals, whichever is later.

Workgroup Leader(s)

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

Workgroup Members

Martin Kulldorff PhD; Alison Kawai PhD; Meghan Baker MD; Inna Dashevsky MS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Michael Nguyen MD; John Scott PhD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

Data Sources
Mini-Sentinel Distributed Database (MSDD)
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