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Pharmacoepidemiolocal Research on Outcomes of Therapeutics by a European ConsorTium

Cel

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 Agency (EMEA), will
develop and test methods of proactive monitoring of drug safety and benefit risk (B/R) assessment utilising a large range of EU data sources and expertise. in partnership with EFP1A companies, PROTECT will develop essential parameters, methodologies and algorithms to enable data mining, signal detection and evaluation in various types of
data-sets including spontaneous reporting, registries and electronic health care databases (EHR). impact analysis
methods will be used to enhance signal prioritisation.
PROTECT will develop means of combining results from clinical trials, spontaneous reporting and observational data, strengthening continuous B/R monitoring in the post-authorisation phase. Bayesian modelling, multi-criteria decision analysis and other analytical methods will be compared. Methods for graphical expression of B/R will be
tested with different stakeholders.
Collection of data directly from patients is underutilized and may be essential when knowledge of total drug consumption or potential confounders is needed or conventional PV is disrupted. PROTECT will trial direct patient data collection in natural language using web-based, telephone and text messaging systems. As well as testing
transferability of the data into a common language, PROTECT will explore linkage to data from EHR and electronic registries.

Dziedzina nauki

Program(-y)

Temat(-y)

Zaproszenie do składania wniosków

IMI-JU-01-2008
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System finansowania

JTI-CP-IMI - Joint Technology Initiatives - Collaborative Project (IMI)

Koordynator

THE EUROPEAN MEDICINES AGENCY
Wkład UE
€ 396 258,00
Adres
DOMENICO SCARLATTILAAN 6
1083 HS Amsterdam
Niderlandy

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Region
West-Nederland Noord-Holland Groot-Amsterdam
Rodzaj działalności
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Kontakt administracyjny
Peter Arlett (Mr)
Kierownik naukowy
Xavier Kurz (Dr.)
Linki
Koszt całkowity
Brak danych

Uczestnicy (34)

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Ostatnia aktualizacja: 12 Kwietnia 2022

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Permalink: https://cordis.europa.eu/project/id/115004/pl

European Union, 2024