Safety Evaluation of Adverse Reactions in Diabetes

Provider

Ministry of Education, Youth and Sports

Programme

—

Call for proposals

FP7-HEALTH-2010-single-stage

Main participants

—

Contest type

RP - Co-financing of EC programme

Contract ID

MSMT-1840/2013-310

Project name in Czech

Safety Evaluation of Adverse Reactions in Diabetes

Annotation in Czech

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 associationswith 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.

R&D category

AP - Applied research

CEP classification - main branch

FB - Endocrinology, diabetology, metabolism, nutrition

CEP - secondary branch

FB - Endocrinology, diabetology, metabolism, nutrition

CEP - another secondary branch

FB - Endocrinology, diabetology, metabolism, nutrition

OECD FORD - equivalent branches <br>(according to the <a href="http://www.vyzkum.cz/storage/att/E6EF7938F0E854BAE520AC119FB22E8D/Prevodnik_oboru_Frascati.pdf">converter</a>)

30202 - Endocrinology and metabolism (including diabetes, hormones)

Provider evaluation

U - Uspěl podle zadání (s publikovanými či patentovanými výsledky atd.)

Project results evaluation

Following the condition that the candidate of financial contribution was evaluated and afterwards selected by international provider in accordance with the rules of the program the Ministry of Education, Youth ans Sports does not realize the evaluation of project results. The project is evaluated only after its approval by an international provider.

Realization period - beginning

Oct 1, 2012

Realization period - end

Sep 30, 2014

Project status

U - Finished project

Latest support payment

Mar 27, 2014

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data delivery code

CEP15-MSM-7E-U/01:1

Data delivery date

Jul 2, 2015

Total approved costs

1,389 thou. CZK

Public financial support

1,389 thou. CZK

Other public sources

0 thou. CZK

Non public and foreign sources

0 thou. CZK