Re-Using Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals via Modular Analytic Programs

Project Title Re-Using Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals via Modular Analytic Programs
Date
Wednesday, August 7, 2013
Location
Description

This article summarizes deliberations of a Mini-Sentinel expert committee on re-use of Mini-Sentinel data to conduct subsequent analyses on the same exposure-outcome pair following rapid assessment of potential safety signals using customizable modular programs.  When appropriate, general non-binding recommendations are provided.

Corresponding Author

S. Toh, Department of Population Medicine, Harvard Pilgrim Healthcare Institute and Harvard Medical School, 401 Park Drive, Suite 401 East, Boston, MA 02215, USA. Email: darren_toh@harvardpilgrim.org

Authors

Sengwee Toh ScD; Jerry Avorn MD; Ralph B. D'Agostino Sr. PhD; Jerry H. Gurwitz MD; Bruce M. Psaty MD, PhD; Kenneth J. Rothman DrPH; Kenneth G. Saag MD, MSc; Miriam C.J.M. Sturkenboom PhD; Jan P. Vandenbroucke MD, PhD; Almut G. Winterstein RPh, PhD; Brian L. Strom MD, MPH

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