Objective "In 2010 a widely marketed drug for the treatment of type 2 diabetes (T2DM) (rosiglitazone) was taken from the market as it was associated with an increased risk of myocardial infarction, a T2DM complication it was actually supposed to prevent. This example shows several things. First, the approval requirements do not guarantee a longer term positive benefit risk profile. Second, large scale postmarketing studies are desperately needed to monitor the benefit risk profile throughout the lifecycle of T2DM drugs, and to achieve the required scale collaboration across countries is mandatory. Many novel T2DM drugs have come to the market, all on the basis of the same surrogate endpoints. New safety issues are constantly arising, such as potential associations with pancreatitis, pancreas cancer, bladder cancer, acute renal failure, etc. In the SAFEGUARD Consortium we have assembled an excellent multidisciplinary group of experts who collaboratively aim to quantify the cardiovascular, cerebrovascular and pancreatic safety risk of the T2DM drugs, in particular the more novel drugs by investigating 1) published clinical trials and observational studies; 2) spontaneously reported adverse event reports in national and international pharmacovigilance databases; 3) data from nine population-based health care databases in six countries capturing longitudinal drug exposure and event data on more than 1.7 million T2DM patients. Data elaboration will be distributed but standardized through common protocols, data models and scripts. To put the epidemiological results into perspective, intensive monitoring mechanistic studies in human will be conducted to further understand how and why these T2DM drugs may affect the cardiovascular, digestive or renal system. The SAFEGUARD consortium will yield a harmonized epidemiological data platform on a large T2DM population, which could easily be used to address newly occurring safety issues in the future." Fields of science medical and health scienceshealth scienceshealth care serviceseHealthnatural sciencescomputer and information sciencesdatabasesmedical and health sciencesclinical medicineendocrinologydiabetes Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH.2011.4.2-2 - Adverse Drug Reaction Research Call for proposal FP7-HEALTH-2011-single-stage See other projects for this call Funding Scheme CP-FP - Small or medium-scale focused research project Coordinator ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM Address Dr molewaterplein 40 3015 GD Rotterdam Netherlands See on map Region West-Nederland Zuid-Holland Groot-Rijnmond Activity type Higher or Secondary Education Establishments Administrative Contact Miriam Cjm Sturkenboom (Prof.) Links Contact the organisation Opens in new window Website Opens in new window EU contribution € 566 342,40 Participants (16) Sort alphabetically Sort by EU Contribution Expand all Collapse all SYNAPSE RESEARCH MANAGEMENT PARTNERS SL Spain EU contribution € 264 896,00 Address Calle velazquez 94 planta 1 28006 Madrid See on map Region Comunidad de Madrid Comunidad de Madrid Madrid Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Mireia Manent (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Stichting Informatievoorziening voor Zorg en Onderzoek Netherlands EU contribution € 0,00 Address Van deventerlaan 3528AE Utrecht See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Heleen Van Engeland (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Fondazione Scientifica SIMG-ONLUS Italy EU contribution € 133 000,00 Address Via del pignoncino 9-11 50142 Firenze See on map Activity type Research Organisations Administrative Contact Carlo Niccolai (Mr.) Links Contact the organisation Opens in new window UNIVERSITY OF BATH United Kingdom EU contribution € 129 400,00 Address Claverton down BA2 7AY Bath See on map Region South West (England) Gloucestershire, Wiltshire and Bristol/Bath area Bath and North East Somerset, North Somerset and South Gloucestershire Activity type Higher or Secondary Education Establishments Administrative Contact Hazel Wallis (Ms.) Links Contact the organisation Opens in new window Website Opens in new window AGENCIA ESPANOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS Spain EU contribution € 116 452,00 Address C/ campezo edificio 8 1 28022 Madrid See on map Region Comunidad de Madrid Comunidad de Madrid Madrid Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Administrative Contact Dolores Montero (Dr.) Links Contact the organisation Opens in new window Website Opens in new window CONSORZIO MARIO NEGRI SUD. Italy EU contribution € 147 550,00 Address Via nazionale 8/a 66030 Santa maria imbaro See on map Activity type Research Organisations Administrative Contact Claude Alain Di Menno Di Bucchianico (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Drug Safety Research Trust United Kingdom EU contribution € 181 600,00 Address Blundell lane, bursledon hal SO31 1AA Southampton See on map Activity type Research Organisations Administrative Contact Chris Atkinson (Mr.) Links Contact the organisation Opens in new window Website Opens in new window UNIVERZITA KARLOVA Czechia EU contribution € 171 524,00 Address Ovocny trh 560/5 116 36 Praha 1 See on map Region Česko Praha Hlavní město Praha Activity type Higher or Secondary Education Establishments Administrative Contact Kristyna Matejkova (Ms.) Links Contact the organisation Opens in new window Website Opens in new window VERENIGING VOOR CHRISTELIJK HOGER ONDERWIJS WETENSCHAPPELIJK ONDERZOEK EN PATIENTENZORG Netherlands EU contribution € 115 005,18 Address De boelelaan 1105 1081 HV Amsterdam See on map Region West-Nederland Noord-Holland Groot-Amsterdam Activity type Higher or Secondary Education Establishments Administrative Contact Ronald Geeve (Mr.) Links Contact the organisation Opens in new window Website Opens in new window BRIGHAM INC United States EU contribution € 223 480,00 Address Francis street 75 02115 Boston ma See on map Activity type Research Organisations Administrative Contact Edith Rosario (Ms.) Links Contact the organisation Opens in new window Website Opens in new window UNIVERSITA' DEGLI STUDI DI MILANO-BICOCCA Italy EU contribution € 211 979,60 Address Piazza dell'ateneo nuovo 1 20126 Milano See on map Region Nord-Ovest Lombardia Milano Activity type Higher or Secondary Education Establishments Administrative Contact Gianpiero Latino (Mr.) Links Contact the organisation Opens in new window Website Opens in new window UNIVERSITAET BREMEN Participation ended Germany EU contribution € 4 336,96 Address Bibliothekstrasse 1 28359 Bremen See on map Region Bremen Bremen Bremen, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Administrative Contact Edeltraut Garbe (Prof.) Links Contact the organisation Opens in new window Website Opens in new window RESEARCH TRIANGLE INSTITUTE United States EU contribution € 231 080,00 Address Cornwallis road 3040 27709 Research triangle park See on map Activity type Research Organisations Administrative Contact Carla Franzoni (Ms.) Links Contact the organisation Opens in new window Website Opens in new window LEIBNIZ-INSTITUT FUR PRAVENTIONSFORSCHUNG UND EPIDEMIOLOGIE - BIPS GMBH Germany EU contribution € 173 855,05 Address Achterstrasse 30 28359 Bremen See on map Region Bremen Bremen Bremen, Kreisfreie Stadt Activity type Other Administrative Contact Xiaogang Gerns (Ms.) Links Contact the organisation Opens in new window Website Opens in new window STICHTING VU Netherlands EU contribution € 214 694,81 Address De boelelaan 1105 1081 HV Amsterdam See on map Region West-Nederland Noord-Holland Groot-Amsterdam Activity type Higher or Secondary Education Establishments Administrative Contact Michaela Diamant (Prof.) Links Contact the organisation Opens in new window Website Opens in new window PHARMO Institute N.V. Netherlands EU contribution € 112 000,00 Address Van deventerlaan 30-40 3528 AE Utrecht See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Heleen Van Engeland (Mrs.) Links Contact the organisation Opens in new window Website Opens in new window
