When Should Case-Only Designs be used for Safety Monitoring of Medical Products?

Project Title When Should Case-Only Designs be used for Safety Monitoring of Medical Products?
Date
Thursday, January 19, 2012
Location
Description

This article describes and evaluates case-only designs for surveillance with administrative databases. The authors review the literature on two designs that are observational analogs to crossover experiments: the self-controlled case series (SCCS) and the case-crossover (CCO) design.

Corresponding Author

M. Maclure, Department Anesthesiology, Pharmacology and Therapeutics, University of British Columbia, 204-1110 Government St, Victoria, BC, Canada V8W 1Y2. E-mail: malcolm.maclure@gov.bc.ca

Authors

Malcolm Maclure SM, SD; Bruce Fireman MA; Jennifer C. Nelson PhD; Wei Hua MD, PhD; Azadeh Shoaibi PhD, MHS, MS; Antonio Paredes PhD; David Madigan PhD

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