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Rock and a Hard Place: Mandated Multi-National Drug Utilization Studies in the Absence of Suitable Secondary Sources of Data

Time

Tue, Jun 17 7:15AM
T 38

Title

Rock and a Hard Place: Mandated Multi-National Drug Utilization Studies in the Absence of Suitable Secondary Sources of Data

Abstract Summary

Increasingly, regulators are mandating multi-national drug utilization studies (DUS) to evaluate (in)appropriate use of medicines. Frequently, however,databases are lacking for all or some countries of interest. Retrospective chart studies can fill these gaps but are associated with significant operational and logistical challenges resulting in higher study execution costs and extended timelines for study sponsors. Design and operational parameters of recent chart review studies of drug utilization and safety conducted in Canada, the United States and Europe have been summarized. Opportunities, challenges and lessons learned are delineated.

Poster Presenter

Krista Payne
MEd,
Executive Director, Senior Research Scientist, Value Demonstration,
United BioSource Corporation
Canada