Safety Evaluation of Adverse Reactions in Diabetes (SAFEGUARD)
Research Areas
At a Glance
- Status: Active Consortium
- Year Launched: 2011
- Initiating Organization: European Commission Seventh Framework Programme (FP7)
- Initiator Type: Government
- Disease focus:
Type 2 Diabetes - Location: Europe
Abstract
The primary aim of the Safety Evaluation of Adverse Reactions in Diabetes (SAFEGUARD) consortium is to assess and further quantify and understand the cardio/cerebrovascular and pancreatic safety of blood glucose–lowering agents, in particular the thiazolidinediones (TZDs) and the novel incretin-based drugs and amylin analogs in Type 2 diabetes mellitus (T2DM) patients. The SAFEGUARD consortium is formed by a multidisciplinary group including diabetes experts, clinicians, pharmacologists, pharmacovigilance experts, statisticians, and pharmacoepidemiologists, and it will capitalize on knowledge generated in other European Union (EU)–funded projects to create a harmonized data platform. This platform will allow for the largest scale studies on T2DM drugs developed so far as well as for the implementation of new epidemiological studies.
Mission
The SAFEGUARD studies include the following:
Consortium History
Oct. 1, 2011: Project started
Sept. 30, 2015: Project ended
Structure & Governance
SAFEGUARD’s work is divided into the following Work Packages (WPs):
WP1 and WP2 provide scientific leadership and operational management to project research. WP3 to WP7 are the main knowledge-generating and scientific work packages, and each deals with different data substrates:
Financing
The funding scheme is through the European Union’s Seventh Framework Programme (small or medium-scale focused research project). The project cost is €3.9 million. Funding is €3.0 million.
Links/Social Media Feed
Homepage |
Points of Contact
Scientific Coordinator:
Miriam Sturkenboom
Department of Medical Informatics
Erasmus University Medical Center
email: m.sturkenboom@erasmusmc.nl
Project Manager:
Mireia Manent
Synapse Research Management Partners S.L.
email: mmanent@synapse-managers.com
Contact: info@safeguard-diabetes.eu
Sponsors & Partners
Agencia Espanola de Medicamentos y Productos Sanitarios |
BIPS Institut fur Epidemiologie und Praventionsforschung GmbhH |
Consorzio Mario Negri Sud |
Drug Safety Research Trust |
Erasmus Medical Center |
Fondaziones Scientifica SIMG-ONLUS |
PHARMO Institute N.V. |
RTI Health Solutions |
Stichting VU-VUMC |
Synapse Research Management Partners |
The Brigham and Women’s Hospital, Harvard Medical School |
Universitaet Bremen |
University of Bath |
University of Milano - Bicocca |
Univerzita Karlova v Praze |