Pharmacoepidemiolocal Research on Outcomes of Therapeutics by a European ConsorTium

Project Information

PROTECT

Grant agreement ID: 115004

Project closed

Start date 1 September 2009

End date 30 April 2015

Funded under

• Specific Programme "Cooperation": Joint Technology Initiatives

Total cost € 28 617 382,00

EU contribution € 11 009 715,00

Coordinated by

THE EUROPEAN MEDICINES AGENCY
Netherlands

Objective

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.

Fields of science

• medical and health sciences › basic medicine › pharmacology and pharmacy › drug safety
• medical and health sciences › health sciences › health care services › eHealth
• natural sciences › computer and information sciences › databases
• natural sciences › computer and information sciences › data science › data mining
• engineering and technology › environmental engineering › energy and fuels › renewable energy › solar energy › photovoltaic

Programme(s)

• FP7-JTI - Specific Programme "Cooperation": Joint Technology Initiatives

Topic(s)

• IMI-JU-01-2008-06 - Strengthening The Monitoring Of Benefit/Risk

Call for proposal

IMI-JU-01-2008
See other projects for this call

Funding Scheme

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

Coordinator

THE EUROPEAN MEDICINES AGENCY

Administrative Contact

Peter Arlett (Mr)

Principal investigator

Xavier Kurz (Dr.)

• EU contribution: € 396 258,00
• Address: DOMENICO SCARLATTILAAN 6 ; 1083 HS Amsterdam ; Netherlands
• Region: West-Nederland › Noord-Holland › Groot-Amsterdam
• Activity type: Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
• Total cost: No data

Participants (34)

Danish Health and Medicines Authority

Denmark

Administrative Contact

Anne Marie Clemensen (Ms)

• EU contribution: € 752 294,00
• Address: Axel Heides Gade ; 2300 Copenhagen S
• Total cost: No data

GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT LTD.

United Kingdom

Administrative Contact

Sally Miles (-)

• EU contribution: No data
• Address: Great West Road 980 ; TW89GS Brentford
• Region: London › Outer London — West and North West › Hounslow and Richmond upon Thames
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: No data

International Alliance of Patients’ Organizations

United Kingdom

Administrative Contact

Joanna Groves (Mrs)

• EU contribution: € 116 294,00
• Address: 703 The Chandlery, 50 Westminster Bridge Road ; SE1 7QY London
• Total cost: No data

Outcome Europe Sarl

Switzerland

Administrative Contact

Manuela Da Silva (Ms.)

• EU contribution: € 983 677,00
• Address: Chemin du Glapin ; 1162 St. Prex
• Total cost: No data

LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN

Germany

Administrative Contact

Joerg Hasford (Univ.-Prof. Dr.)

• EU contribution: € 346 803,00
• Address: GESCHWISTER SCHOLL PLATZ 1 ; 80539 Muenchen
• Region: Bayern › Oberbayern › München, Kreisfreie Stadt
• Activity type: Higher or Secondary Education Establishments
• Total cost: No data

AGENCIA ESPANOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS

Spain

Administrative Contact

JoseLuis Alonso Lebrero (Dr)

• EU contribution: € 374 520,00
• Address: c/ Campezo Edificio 8 1 ; 28022 Madrid
• Region: Comunidad de Madrid › Comunidad de Madrid › Madrid
• Activity type: Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
• Total cost: No data

Fundacio' Institut Català de Farmacologia

Spain

Administrative Contact

Montse Pérez (-)

• EU contribution: € 622 643,00
• Address: Pg. Vall d’Hebron ; 08035 Barcelona
• Total cost: No data

Fundación Centro Español de Investigación Farmacoepidemiológica

Spain

Administrative Contact

Luis Alberto García Rodríguez (Dr)

• EU contribution: € 280 450,00
• Address: Almirante ; 28004 Madrid
• Total cost: No data

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE

France

Administrative Contact

Mihaja AUGUSTE (Mrs)

• EU contribution: € 539 760,00
• Address: RUE DE TOLBIAC 101 ; 75654 Paris
• Region: Ile-de-France › Ile-de-France › Paris
• Activity type: Research Organisations
• Total cost: No data

L.A SANTE, EPIDEMIOLOGIE, EVALUATION ET RECHERCHE L.A.S.E.R.

France

Administrative Contact

Micheline LEVY-ABENHAIM (Ms.)

• EU contribution: € 1 400 657,00
• Address: IMMEUBLE CIT 3 RUE DE L'ARIVEE ; 75015 Paris
• Region: Ile-de-France › Ile-de-France › Paris
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: No data

ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

Italy

Administrative Contact

Maria Grazia Pezzoni (Ms)

• EU contribution: € 232 500,00
• Address: VIA MARIO NEGRI 2 ; 20156 Milano
• Region: Nord-Ovest › Lombardia › Milano
• Activity type: Research Organisations
• Total cost: No data

RIJKSUNIVERSITEIT GRONINGEN

Netherlands

Administrative Contact

Abe Ebbes (Mr)

• EU contribution: € 329 741,00
• Address: Broerstraat 5 ; 9712CP Groningen
• Region: Noord-Nederland › Groningen › Overig Groningen
• Activity type: Higher or Secondary Education Establishments
• Total cost: No data

UNIVERSITEIT UTRECHT

Netherlands

Administrative Contact

Rinske De Kok-Baan (Ms.)

• EU contribution: € 1 428 695,00
• Address: HEIDELBERGLAAN 8 ; 3584 CS Utrecht
• Region: West-Nederland › Utrecht › Utrecht
• Activity type: Higher or Secondary Education Establishments
• Total cost: No data

Stiftelsen WHO Collaborating Centre for International Drug Monitoring

Sweden

Administrative Contact

Birgitta Toreheim (CFO)

• EU contribution: € 1 013 796,00
• Address: Bredgrand 7 ; S-75140 Uppsala
• Region: Östra Sverige › Östra Mellansverige › Uppsala län
• Activity type: Research Organisations
• Total cost: No data

Department of Health

United Kingdom

Administrative Contact

Richard Humphreys (Mr)

• EU contribution: € 492 896,00
• Address: Quarry House, Quarry Hill ; LS2 7UE Leeds
• Region: Yorkshire and the Humber › West Yorkshire › Leeds
• Activity type: Research Organisations
• Total cost: No data

IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE

United Kingdom

Administrative Contact

Tatjana Palalic (Miss)

• EU contribution: € 767 316,00
• Address: SOUTH KENSINGTON CAMPUS EXHIBITION ROAD ; SW7 2AZ LONDON
• Region: London › Inner London — West › Westminster
• Activity type: Higher or Secondary Education Establishments
• Total cost: No data

UNIVERSITY OF NEWCASTLE UPON TYNE

United Kingdom

Administrative Contact

Aleona Blinova (Ms)

• EU contribution: € 244 890,00
• Address: KINGS GATE ; NE1 7RU Newcastle Upon Tyne
• Region: North East (England) › Northumberland and Tyne and Wear › Tyneside
• Activity type: Higher or Secondary Education Establishments
• Total cost: No data

SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT

France

Administrative Contact

Bernd Stowasser (Dr.)

• EU contribution: No data
• Address: 82 AVENUE RASPAIL ; 94250 GENTILLY
• Region: Ile-de-France › Ile-de-France › Val-de-Marne
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: No data

PFIZER LIMITED

United Kingdom

Administrative Contact

Olga Krylova (Dr)

• EU contribution: No data
• Address: RAMSGATE ROAD ; CT13 9NJ Sandwich
• Region: South East (England) › Kent › East Kent
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: No data

F. HOFFMANN-LA ROCHE AG

Switzerland

Administrative Contact

Sebastian Horn (Dr.med.)

• EU contribution: No data
• Address: GRENZACHERSTRASSE 124 ; 4070 Basel
• Region: Schweiz/Suisse/Svizzera › Nordwestschweiz › Basel-Stadt
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: No data

NOVARTIS PHARMA AG

Switzerland

Administrative Contact

Dieter Nussher (-)

• EU contribution: No data
• Address: LICHTSTRASSE 35 ; 4056 Basel
• Region: Schweiz/Suisse/Svizzera › Nordwestschweiz › Basel-Stadt
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: No data

AMGEN

Belgium

Administrative Contact

Simon Gibbs (Mr)

• EU contribution: No data
• Address: TELECOMLAAN 5-7 ; 1831 Diegem
• Region: Vlaams Gewest › Prov. Vlaams-Brabant › Arr. Halle-Vilvoorde
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: No data

Genzyme Europe B.V.

Netherlands

Administrative Contact

Ingeborg Steneker (Mrs.)

• EU contribution: No data
• Address: Gooimeer ; 1411 DD Naarden
• Total cost: No data

MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN

Germany

Administrative Contact

Ninog Péresse (Mrs.)

• EU contribution: No data
• Address: FRANKFURTER STRASSE 250 ; 64293 Darmstadt
• Region: Hessen › Darmstadt › Darmstadt, Kreisfreie Stadt
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: No data

Bayer Pharma AG

Germany

Administrative Contact

Burkhardt Neumann (Mr.)

• EU contribution: No data
• Address: Muellerstrasse 178 ; 13353 Berlin
• Region: Berlin › Berlin › Berlin
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: No data

ASTRAZENECA AB

Sweden

Administrative Contact

Eva Lindgren (Ms)

• EU contribution: No data
• Address: Vastra Maelarhamnen ; 151 85 Sodertaelje
• Region: Östra Sverige › Stockholm › Stockholms län
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: No data

H. LUNDBECK AS

Denmark

Administrative Contact

Jens Peter Balling (MD)

• EU contribution: No data
• Address: OTTILIAVEJ 7-9 ; 2500 Valby
• Region: Danmark › Hovedstaden › Byen København
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: No data

NOVO NORDISK A/S

Denmark

Administrative Contact

Morten Colding-Jørgensen (MD, M.Sc)

• EU contribution: No data
• Address: NOVO ALLE 1 ; 2880 Bagsvaerd
• Region: Danmark › Hovedstaden › Københavns omegn
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: No data

UNIWERSYTET MEDYCZNY IM KAROLA MARCINKOWSKIEGO W POZNANIU

Poland

Administrative Contact

Bozena Raducha (M.A.)

• EU contribution: € 57 014,00
• Address: UL. FREDRY 10 ; 61-701 Poznan
• Region: Makroregion północno-zachodni › Wielkopolskie › Miasto Poznań
• Activity type: Higher or Secondary Education Establishments
• Total cost: No data

TAKEDA DEVELOPMENT CENTRE EUROPE LTD

United Kingdom

Administrative Contact

Julie Bass (Ms)

• EU contribution: No data
• Address: ALDWYCH 61 ; WC2B 4AE London
• Region: London › Inner London — West › Westminster
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: No data

AARHUS UNIVERSITET

Denmark

Administrative Contact

Karin Lykke (Ms)

• EU contribution: € 322 087,00
• Address: NORDRE RINGGADE 1 ; 8000 Aarhus C
• Region: Danmark › Midtjylland › Østjylland
• Activity type: Higher or Secondary Education Establishments
• Total cost: No data

ELI LILLY AND COMPANY LTD

United Kingdom

Administrative Contact

Birgit Steckel-Hamann (Dr)

• EU contribution: No data
• Address: LILLY HOUSE BASINGVIEW ; RG21 4FA Basingstoke
• Region: South East (England) › Hampshire and Isle of Wight › North Hampshire
• Activity type: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Total cost: No data

Private Universitaet Witten/Herdecke gGmbH

Germany

Administrative Contact

Regina Steinkaul (B.A.)

• EU contribution: € 38 820,00
• Address: Alfred-Herrhaussen Strasse 50 ; 58455 Witten
• Region: Nordrhein-Westfalen › Arnsberg › Ennepe-Ruhr-Kreis
• Activity type: Higher or Secondary Education Establishments
• Total cost: No data

ACADEMISCH ZIEKENHUIS GRONINGEN

Netherlands

Administrative Contact

Joanna M Van Apeldoorn (Ms)

• EU contribution: € 268 604,00
• Address: HANZEPLEIN 1 ; 9713 GZ Groningen
• Region: Noord-Nederland › Groningen › Overig Groningen
• Activity type: Higher or Secondary Education Establishments
• Total cost: No data