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Safety Evaluation of Adverse Reactions in Diabetes

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."

Call for proposal

FP7-HEALTH-2011-single-stage
See other projects for this call

Coordinator

ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Address
Dr Molewaterplein 40
3015 GD Rotterdam
Netherlands
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 566 342,40
Administrative Contact
Miriam Cjm Sturkenboom (Prof.)

Participants (16)

SYNAPSE RESEARCH MANAGEMENT PARTNERS SL
Spain
EU contribution
€ 264 896
Address
Calle Velazquez 94 Planta 1
28006 Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Mireia Manent (Ms.)
Stichting Informatievoorziening voor Zorg en Onderzoek
Netherlands
Address
Van Deventerlaan
3528AE Utrecht
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Heleen Van Engeland (Ms.)
Fondazione Scientifica SIMG-ONLUS
Italy
EU contribution
€ 133 000
Address
Via Del Pignoncino 9-11
50142 Firenze
Activity type
Research Organisations
Administrative Contact
Carlo Niccolai (Mr.)
UNIVERSITY OF BATH
United Kingdom
EU contribution
€ 129 400
Address
Claverton Down
BA2 7AY Bath
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Hazel Wallis (Ms.)
AGENCIA ESPANOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS
Spain
EU contribution
€ 116 452
Address
C/ Campezo Edificio 8 1
28022 Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Dolores Montero (Dr.)
CONSORZIO MARIO NEGRI SUD.
Italy
EU contribution
€ 147 550
Address
Via Nazionale 8/A
66030 Santa Maria Imbaro
Activity type
Research Organisations
Administrative Contact
Claude Alain Di Menno Di Bucchianico (Mr.)
Drug Safety Research Trust
United Kingdom
EU contribution
€ 181 600
Address
Blundell Lane, Bursledon Hal
SO31 1AA Southampton
Activity type
Research Organisations
Administrative Contact
Chris Atkinson (Mr.)
UNIVERZITA KARLOVA
Czechia
EU contribution
€ 171 524
Address
Ovocny Trh 560/5
116 36 Praha 1
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Kristyna Matejkova (Ms.)
VERENIGING VOOR CHRISTELIJK HOGER ONDERWIJS WETENSCHAPPELIJK ONDERZOEK EN PATIENTENZORG
Netherlands
EU contribution
€ 115 005,18
Address
De Boelelaan 1105
1081 HV Amsterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ronald Geeve (Mr.)
THE BRIGHAM AND WOMEN'S HOSPITAL INC
United States
EU contribution
€ 223 480
Address
Francis Street 75
02241 Boston Ma
Activity type
Research Organisations
Administrative Contact
Edith Rosario (Ms.)
UNIVERSITA' DEGLI STUDI DI MILANO-BICOCCA
Italy
EU contribution
€ 211 979,60
Address
Piazza Dell'ateneo Nuovo 1
20126 Milano
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Gianpiero Latino (Mr.)
UNIVERSITAET BREMEN

Participation ended

Germany
EU contribution
€ 4 336,96
Address
Bibliothekstrasse 1
28359 Bremen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Edeltraut Garbe (Prof.)
RESEARCH TRIANGLE INSTITUTE
United States
EU contribution
€ 231 080
Address
Cornwallis Road 3040
27709 Research Triangle Park
Activity type
Research Organisations
Administrative Contact
Carla Franzoni (Ms.)
LEIBNIZ-INSTITUT FUR PRAVENTIONSFORSCHUNG UND EPIDEMIOLOGIE - BIPS GMBH
Germany
EU contribution
€ 173 855,05
Address
Achterstrasse 30
28359 Bremen
Activity type
Other
Administrative Contact
Xiaogang Gerns (Ms.)
STICHTING VU
Netherlands
EU contribution
€ 214 694,81
Address
De Boelelaan 1105
1081 HV Amsterdam
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Michaela Diamant (Prof.)
PHARMO Institute N.V.
Netherlands
EU contribution
€ 112 000
Address
Van Deventerlaan 30-40
3528 AE Utrecht
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Heleen Van Engeland (Mrs.)