CORDIS Project
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The SAFEGUARD Consortium aims to assess the safety risks of type 2 diabetes medications, particularly new drugs, by analyzing clinical trials, adverse event reports, and health data from millions of patients. The project seeks to create a standardized data platform for ongoing safety monitoring.
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…
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Partner organizations (coordinator is shown above), with normalized type and CORDIS activity type. Guests see up to 4 partners.
Spain, Madrid
Type: SME
Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
SME: Yes
Netherlands, Utrecht
Type: Company (for-profit)
Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
United Kingdom, Bath
Type: University / higher education
Activity type: Higher or Secondary Education Establishments
SME: No
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