4 projets européens trouvés
Recherche sur 125080 projets européens
TERMINÉ
European Prevention of Alzheimer’s Dementia Consortium (EPAD)
Date du début: 1 janv. 2015, Date de fin: 31 déc. 2019,
Background:The secondary prevention of Alzheimer’s dementia (AD) is achievable if we can identify individuals at risk of disease progression defined by biomarker evidence of AD pathology and no or only minimal clinical symptoms and engage them in a standing adaptive clinical trial, of the highest quality, testing multiple interventions. To achieve this, EPAD will also provide the analytical infras ...
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40
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TERMINÉ
Incorporating real-life clinical data into drug development (GETREAL)
Date du début: 1 oct. 2013, Date de fin: 31 déc. 2016,
When a new medicine reaches the market, it is accompanied by an extensive data package that provides information about the safety and efficacy of the medicine in a clinical trial setting. However, assessing the expected future value of the medicines when used in “real world” clinical practice requires additional information next to traditional (pre-authorisation) clinical trials. Regulatory, HTA ...
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32
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TERMINÉ
SAFER AND FASTER EVIDENCE-BASED TRANSLATION (SAFE-T)
Date du début: 15 juin 2009, Date de fin: 14 juin 2015,
The public-private consortium composed of complementary SMEs, academic and clinical centers of excellence and EMEA as partner proposes SAFE-T (Safer And Easter Evidence-based Iranslation) project for the establishment of a biomarker (BM) qualification process and its validation in clinical biomarker studies designed for the translation, performance testing and eventual regulatory qualifIcatIon of ...
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26
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TERMINÉ
Pharmacoepidemiolocal Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT)
Date du début: 1 sept. 2009, Date de fin: 30 avr. 2015,
Recent pharmacovigilance (PV) issues have led to questions regarding the ability of the current PV system to meet the global needs. Controversies around the assessment of spontaneous reports and conflicting results from pharmacoepidemiology studies may lead to delay in, or inappropriate, regulatory decisions. The PROTECT consortium, consisting of 20 core partners lead by the European Medicines Age ...
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