EMEA PROTECT-EU

Outcome Europe Sàrl, the European subsidiary of Outcome Sciences, Inc. the leading provider of patient registries, studies, and technologies for evaluating real-world outcomes, has been selected as a partner for the European Medicines Agency’s (EMA) PROTECT-EU project (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium), a multinational collaboration of 31 public, private and academic organizations that have come together to develop innovative methods in pharmacoepidemiology and pharmacovigilance. The project started in September 2009 and will run for over five years, with a total funding of EUR 20 million.

PROTECT-EU will look at the limitations of current methods used in pharmacovigilance and pharmacoepidemiology in order to strengthen the monitoring of the benefit/risk balance of medicines marketed in Europe. A set of innovative tools and methods will be developed and validated in specialized Work Packages, including: (1) modern tools of communication to directly collect data from consumers of medicines; (2) improved tools for early and proactive detection of signals; (3) a framework for the design, conduct and analysis of pharmacoepidemiological studies; and (4) methods for continuous benefit/risk monitoring, with a particular emphasis on graphical methods to display benefit/risk profiles.

Outcome’s Chief of Scientific Affairs and Senior Vice President, Nancy Dreyer MPH, PhD, has been selected as the alternate co-leader of Work Package 4 and is a member of PROTECT-EU’s Steering Committee. Outcome will provide the tools to support Work Package 4 in order to evaluate the quality of information on self reported drug use (prescription, over the counter, and herbal and complementary medicines) collected via the internet and interactive voice response in the natural language in four countries. In the United Kingdom and Denmark specifically, the patients’ reported use of prescription drugs will be compared with prescription drug data maintained independently in those countries. Understanding how well patients report their own drug use, and what areas they tend to over report or under report, will allow for greater efficiency in study design in the future.

To learn more, contact us at info@outcome.com or visit the PROTECT-EU website at www.imi-protect.eu/.