SAFEGUARD
Safety Evaluation of Adverse Reactions in Diabetes
| Coordinatore | ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Organization address
address: 's Gravendijkwal 230 contact info |
| Nazionalità Coordinatore | Netherlands [NL] |
| Totale costo | 3˙881˙341 € |
| EC contributo | 2˙997˙196 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2011-single-stage |
| Funding Scheme | CP-FP |
| Anno di inizio | 2011 |
| Periodo (anno-mese-giorno) | 2011-10-01 - 2015-09-30 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Organization address
address: 's Gravendijkwal 230 contact info |
NL (ROTTERDAM) | coordinator | 566˙342.40 |
| 2 |
SYNAPSE RESEARCH MANAGEMENT PARTNERS SL
Organization address
address: CALLE LLACUNA 162 contact info |
ES (BARCELONA) | participant | 264˙896.00 |
| 3 |
RESEARCH TRIANGLE INSTITUTE
Organization address
address: CORNWALLIS ROAD 3040 contact info |
US (RESEARCH TRIANGLE PARK) | participant | 231˙080.00 |
| 4 |
The Brigham and Women's Hospital, Inc.
Organization address
address: Francis Street 75 contact info |
US (Boston) | participant | 223˙480.00 |
| 5 |
STICHTING VU-VUMC
Organization address
address: DE BOELELAAN 1105 contact info |
NL (AMSTERDAM) | participant | 214˙694.81 |
| 6 |
UNIVERSITA' DEGLI STUDI DI MILANO-BICOCCA
Organization address
address: PIAZZA DELL'ATENEO NUOVO 1 contact info |
IT (MILANO) | participant | 211˙979.60 |
| 7 |
Drug Safety Research Trust
Organization address
address: "Blundell Lane, Bursledon Hal" contact info |
UK (Southampton) | participant | 181˙600.00 |
| 8 |
BIPS - INSTITUT FUR EPIDEMIOLOGIE UND PRAVENTIONSFORSCHUNG GMBH
Organization address
address: ACHTERSTRASSE 30 contact info |
DE (BREMEN) | participant | 173˙855.05 |
| 9 |
UNIVERZITA KARLOVA V PRAZE
Organization address
address: Ovocny trh 5 contact info |
CZ (PRAHA 1) | participant | 171˙524.00 |
| 10 |
FONDAZIONE MARIO NEGRI SUD-CENTRO DI RICERCHE FARMACOLOGICHE EB IOMEDICHE
Organization address
address: Via Nazionale 8/A contact info |
IT (SANTA MARIA IMBARO) | participant | 147˙550.00 |
| 11 |
Fondazione Scientifica SIMG-ONLUS
Organization address
address: Via del Pignoncino 9-11 contact info |
IT (Firenze) | participant | 133˙000.00 |
| 12 |
UNIVERSITY OF BATH
Organization address
address: CLAVERTON DOWN contact info |
UK (BATH) | participant | 129˙400.00 |
| 13 |
AGENCIA ESPANOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS
Organization address
address: c/ Campezo Edificio 8 1 contact info |
ES (MADRID) | participant | 116˙452.00 |
| 14 |
VERENIGING VOOR CHRISTELIJK HOGER ONDERWIJS WETENSCHAPPELIJK ONDERZOEK EN PATIENTENZORG
Organization address
address: De Boelelaan 1105 contact info |
NL (AMSTERDAM) | participant | 115˙005.18 |
| 15 |
PHARMO Institute N.V.
Organization address
address: Van Deventerlaan 30-40 contact info |
NL (Utrecht) | participant | 112˙000.00 |
| 16 |
UNIVERSITAET BREMEN
Organization address
address: Bibliothekstrasse 1 contact info |
DE (BREMEN) | participant | 4˙336.96 |
| 17 |
PHARMO COOPERATIE UA
Organization address
address: VAN DEVENTERLAAN 30-40 contact info |
NL (UTRECHT) | participant | 0.00 |
Mappa
Word cloud
Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.
Obiettivo del progetto (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.'