(P-567) SIGMA Consortium: A New Era of Collaboration to Study the Safety and Effectiveness of Medical Interventions

Background: European research institutions have long demonstrated the potential for collaboration, including that involving federated analyses. In order to further solidify the collaboration, the SIGMA Consortium was launched to provide trusted pharmacoepidemiologic and real-world evidence research through a European federated professional network of excellence.

Objectives: To describe the vision, goals and experience of the SIGMA Consortium – an alliance of research centres of excellence in pharmacoepidemiology in Europe.

Methods: The SIGMA Consortium is formed by several European universities and other leading research institutions with extensive expertise and experience in the conduct of pharmacoepidemiologic real-world evidence research under the principles of the European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP).

Results: The SIGMA Consortium is currently formed by 11 institutions and universities from Denmark, France, Germany, Italy, the Netherlands, Spain and the United Kingdom. Members of the SIGMA Consortium have extensive collective experience in collaborating in more than 40 multi-country studies. All members are dedicated to excellence in research by adhering to the ENCePP Guide on Methodological Standards and promoting scientific independence and transparency. SIGMA members have access to different sources of real-world data including prescription/dispensing, hospital and primary care, laboratory, cancer and pregnancy data of together more than 100 million persons across Europe. Study funder institutions can contact the SIGMA Office for research requests. Each request will be distributed to all SIGMA members with interest and availability to participate in the study in the role(s) of Coordinating Centre, Principal Investigator Centre and/or Research Site.

Conclusions: The SIGMA Consortium aspires to serve as a trusted hub for the planning, design, analyses, interpretation and dissemination of European pharmacoepidemiologic real-world evidence studies, providing a one-stop shop for research services. Based on the long-standing collaborative experience of its members, the formalization of the SIGMA Consortium is a powerful tool to facilitate coordination with its partners and allow rational and efficient use of resources. SIGMA also constitutes a unique source in Europe of extensive shared experiences in the field of advanced pharmacoepidemiology, which can be easily deployed. The SIGMA Consortium’s vision is to provide best-quality evidence on the use, benefits and harms of medications, vaccines and medical devices for the betterment of public health and patient care.