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PROTECT

Financiado

Pharmacoepidemiolocal Research on Outcomes of Therapeutics by a European ConsorT...

Pharmacoepidemiolocal Research on Outcomes of Therapeutics by a European ConsorTium 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 pharmacoep... ver más

30/04/2015

EMA

29M€

Presupuesto del proyecto: 29M€

Líder del proyecto

THE EUROPEAN MEDICINES AGENCY No se ha especificado una descripción o un objeto social para esta compañía.

Ver 30 Participantes

Financiación concedida El organismo FP7 notifico la concesión del proyecto el día 2015-04-30 No tenemos la información de la convocatoria

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30 Participantes

EMA

0.00€ | Lider

SARD

N.D. | Participante

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Líder del proyecto

THE EUROPEAN MEDICINES AGENCY No se ha especificado una descripción o un objeto social para esta compañía.

Presupuesto del proyecto 29M€

Descripción del proyecto 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.

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