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

Basic Details
Date
Type
Publication
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.

Materials

Pharmacoepidemiology and Drug Safety, Volume 21, Issue Supplement S1, January 2012, Pages 50-61, DOI: 10.1002/pds.2330

Related Assessment(s)
Case-Based Methods
PDS Supplement: The U.S. Food and Drug Administration's Mini-Sentinel Program
Author(s)

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

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