The IMI PROTECT project: Purpose, organizational structure, and procedures

Robert F Reynolds; Xavier Kurz; Mark C H de Groot; Raymond G Schlienger; Lamiae Grimaldi-Bensouda; Stéphanie Tcherny-Lessenot; Olaf H Klungel; Yolanda Alvarez; Gianmario Candore; Jean-Louis Durand; Jim Slattery; J. Hasford; Marietta Rottenkolber; Sven Schmiedl; F. de Abajo Iglesias; M Gil; Juan R González; C. Huerta Alvarez; E. Martin; Baldomero Oliva; Gema Requena; J. Amelio; Ruth Brauer; Gerald Downey; M. Feudjo-Tepie; M. Schoonen; S. Johansson; J. Robinson; M. Schuerch; I. Tatt; L. A. Garcia; Ana Ruigomez; J J Campbell; A Gallagher; Kwee Eng Ng; Tjeerd P. van Staa; O. Demol; N. Boudiaf; K Davis; John Logie; J. Pimenta; R. Beau-Lejdstrom; Lucien Abenhaim; Michel Rossignol; U. Hesse; P F Rønn; Montserrat Miret; J. Fortuny; P. Primatesta; E. Rivero; Raymond G Schlienger; C A Bate; N. Gatto; E. Ballarin; Pilar Ferrer-Escorihuela; Manuel Lopez-Ibanez; J. R. Laporte; Manel Sabaté; Victoria Abbing-Karahagopian; S Ali; Domir De Bakker; Svetlana V Belitser; A. De Boer; A C G Egberts; L van Dijk; Helga Gardarsdottir; Rolf H H Groenwold; Arno W Hoes; Hubert G M Leufkens; W. Pestman; K. C B Roes; Patrick Cyriel Souverein; Frans H Rutten; J. Uddin; Hendrika A. van den Ham; E. Voogd; Franciska de Vries; M. L. De Bruin; L Auclert; Juhaeri Juhaeri; L. Mazuranok; Lesley Wise; D Stewart Irvine; Paul Dolin; Christiane Gasse

doi:10.1002/pds.3933

The IMI PROTECT project: Purpose, organizational structure, and procedures

Robert F Reynolds, Xavier Kurz, Mark C H de Groot, Raymond G Schlienger, Lamiae Grimaldi-Bensouda, Stéphanie Tcherny-Lessenot, Olaf H Klungel, Yolanda Alvarez, Gianmario Candore, Jean-Louis Durand, Jim Slattery, J. Hasford, Marietta Rottenkolber, Sven Schmiedl, F. de Abajo Iglesias, M Gil, Juan R González, C. Huerta Alvarez, E. Martin, Baldomero OlivaGema Requena, J. Amelio, Ruth Brauer, Gerald Downey, M. Feudjo-Tepie, M. Schoonen, S. Johansson, J. Robinson, M. Schuerch, I. Tatt, L. A. Garcia, Ana Ruigomez, J J Campbell, A Gallagher, Kwee Eng Ng, Tjeerd P. van Staa, O. Demol, N. Boudiaf, K Davis, John Logie, J. Pimenta, R. Beau-Lejdstrom, Lucien Abenhaim, Michel Rossignol, U. Hesse, P F Rønn, Montserrat Miret, J. Fortuny, P. Primatesta, E. Rivero, Raymond G Schlienger, C A Bate, N. Gatto, E. Ballarin, Pilar Ferrer-Escorihuela, Manuel Lopez-Ibanez, J. R. Laporte, Manel Sabaté, Victoria Abbing-Karahagopian, S Ali, Domir De Bakker, Svetlana V Belitser, A. De Boer, A C G Egberts, L van Dijk, Helga Gardarsdottir, Rolf H H Groenwold, Arno W Hoes, Hubert G M Leufkens, W. Pestman, K. C B Roes, Patrick Cyriel Souverein, Frans H Rutten, J. Uddin, Hendrika A. van den Ham, E. Voogd, Franciska de Vries, M. L. De Bruin, L Auclert, Juhaeri Juhaeri, L. Mazuranok, Lesley Wise, D Stewart Irvine, Paul Dolin, Christiane Gasse

15 Citations (Scopus)

Abstract

The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) initiative was a collaborative European project that sought to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. Initiated in 2009 and ending in 2015, PROTECT was part of the Innovative Medicines Initiative, a joint undertaking by the European Union and pharmaceutical industry. Thirty-five partners including academics, regulators, small and medium enterprises, and European Federation of Pharmaceuticals Industries and Associations companies contributed to PROTECT. Two work packages within PROTECT implemented research examining the extent to which differences in the study design, methodology, and choice of data source can contribute to producing discrepant results from observational studies on drug safety. To evaluate the effect of these differences, the project applied different designs and analytic methodology for six drug-adverse event pairs across several electronic healthcare databases and registries. This papers introduces the organizational structure and procedures of PROTECT, including how drug-adverse event and data sources were selected, study design and analyses documents were developed, and results managed centrally.

Original language	English
Journal	Pharmacoepidemiology and Drug Safety
Volume	25
Issue number	suppl 51
Pages (from-to)	5-10
Number of pages	6
ISSN	1053-8569
DOIs	https://doi.org/10.1002/pds.3933
Publication status	Published - 1 Mar 2016
Externally published	Yes

Keywords

Electronic healthcare databases
European Medicines Agency
Innovative Medicines Initiative
Methodology
Observational studies
Pharmacoepidemiology
PROTECT

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Reynolds, R. F., Kurz, X., de Groot, M. C. H., Schlienger, R. G., Grimaldi-Bensouda, L., Tcherny-Lessenot, S., Klungel, O. H., Alvarez, Y., Candore, G., Durand, J.-L., Slattery, J., Hasford, J., Rottenkolber, M., Schmiedl, S., de Abajo Iglesias, F., Gil, M., González, J. R., Huerta Alvarez, C., Martin, E., ... Gasse, C. (2016). The IMI PROTECT project: Purpose, organizational structure, and procedures. Pharmacoepidemiology and Drug Safety, 25(suppl 51), 5-10. https://doi.org/10.1002/pds.3933

Reynolds, RF, Kurz, X, de Groot, MCH, Schlienger, RG, Grimaldi-Bensouda, L, Tcherny-Lessenot, S, Klungel, OH, Alvarez, Y, Candore, G, Durand, J-L, Slattery, J, Hasford, J, Rottenkolber, M, Schmiedl, S, de Abajo Iglesias, F, Gil, M, González, JR, Huerta Alvarez, C, Martin, E, Oliva, B, Requena, G, Amelio, J, Brauer, R, Downey, G, Feudjo-Tepie, M, Schoonen, M, Johansson, S, Robinson, J, Schuerch, M, Tatt, I, Garcia, LA, Ruigomez, A, Campbell, JJ, Gallagher, A, Ng, KE, van Staa, TP, Demol, O, Boudiaf, N, Davis, K, Logie, J, Pimenta, J, Beau-Lejdstrom, R, Abenhaim, L, Rossignol, M, Hesse, U, Rønn, PF, Miret, M, Fortuny, J, Primatesta, P, Rivero, E, Schlienger, RG, Bate, CA, Gatto, N, Ballarin, E, Ferrer-Escorihuela, P, Lopez-Ibanez, M, Laporte, JR, Sabaté, M, Abbing-Karahagopian, V, Ali, S, De Bakker, D, Belitser, SV, De Boer, A, Egberts, ACG, van Dijk, L, Gardarsdottir, H, Groenwold, RHH, Hoes, AW, Leufkens, HGM, Pestman, W, Roes, KCB, Souverein, PC, Rutten, FH, Uddin, J, van den Ham, HA, Voogd, E, de Vries, F, De Bruin, ML, Auclert, L, Juhaeri, J, Mazuranok, L, Wise, L, Irvine, DS, Dolin, P & Gasse, C 2016, 'The IMI PROTECT project: Purpose, organizational structure, and procedures', Pharmacoepidemiology and Drug Safety, vol. 25, no. suppl 51, pp. 5-10. https://doi.org/10.1002/pds.3933

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abstract = "The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium (PROTECT) initiative was a collaborative European project that sought to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. Initiated in 2009 and ending in 2015, PROTECT was part of the Innovative Medicines Initiative, a joint undertaking by the European Union and pharmaceutical industry. Thirty-five partners including academics, regulators, small and medium enterprises, and European Federation of Pharmaceuticals Industries and Associations companies contributed to PROTECT. Two work packages within PROTECT implemented research examining the extent to which differences in the study design, methodology, and choice of data source can contribute to producing discrepant results from observational studies on drug safety. To evaluate the effect of these differences, the project applied different designs and analytic methodology for six drug-adverse event pairs across several electronic healthcare databases and registries. This papers introduces the organizational structure and procedures of PROTECT, including how drug-adverse event and data sources were selected, study design and analyses documents were developed, and results managed centrally.",

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language = "English",

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T1 - The IMI PROTECT project

T2 - Purpose, organizational structure, and procedures

AU - Reynolds, Robert F

AU - Kurz, Xavier

AU - de Groot, Mark C H

AU - Schlienger, Raymond G

AU - Grimaldi-Bensouda, Lamiae

AU - Tcherny-Lessenot, Stéphanie

AU - Klungel, Olaf H

AU - Alvarez, Yolanda

AU - Candore, Gianmario

AU - Durand, Jean-Louis

AU - Slattery, Jim

AU - Hasford, J.

AU - Rottenkolber, Marietta

AU - Schmiedl, Sven

AU - de Abajo Iglesias, F.

AU - Gil, M

AU - González, Juan R

AU - Huerta Alvarez, C.

AU - Martin, E.

AU - Oliva, Baldomero

AU - Requena, Gema

AU - Amelio, J.

AU - Brauer, Ruth

AU - Downey, Gerald

AU - Feudjo-Tepie, M.

AU - Schoonen, M.

AU - Johansson, S.

AU - Robinson, J.

AU - Schuerch, M.

AU - Tatt, I.

AU - Garcia, L. A.

AU - Ruigomez, Ana

AU - Campbell, J J

AU - Gallagher, A

AU - Ng, Kwee Eng

AU - van Staa, Tjeerd P.

AU - Demol, O.

AU - Boudiaf, N.

AU - Davis, K

AU - Logie, John

AU - Pimenta, J.

AU - Beau-Lejdstrom, R.

AU - Abenhaim, Lucien

AU - Rossignol, Michel

AU - Hesse, U.

AU - Rønn, P F

AU - Miret, Montserrat

AU - Fortuny, J.

AU - Primatesta, P.

AU - Rivero, E.

AU - Schlienger, Raymond G

AU - Bate, C A

AU - Gatto, N.

AU - Ballarin, E.

AU - Ferrer-Escorihuela, Pilar

AU - Lopez-Ibanez, Manuel

AU - Laporte, J. R.

AU - Sabaté, Manel

AU - Abbing-Karahagopian, Victoria

AU - Ali, S

AU - De Bakker, Domir

AU - Belitser, Svetlana V

AU - De Boer, A.

AU - Egberts, A C G

AU - van Dijk, L

AU - Gardarsdottir, Helga

AU - Groenwold, Rolf H H

AU - Hoes, Arno W

AU - Leufkens, Hubert G M

AU - Pestman, W.

AU - Roes, K. C B

AU - Souverein, Patrick Cyriel

AU - Rutten, Frans H

AU - Uddin, J.

AU - van den Ham, Hendrika A.

AU - Voogd, E.

AU - de Vries, Franciska

AU - De Bruin, M. L.

AU - Auclert, L

AU - Juhaeri, Juhaeri

AU - Mazuranok, L.

AU - Wise, Lesley

AU - Irvine, D Stewart

AU - Dolin, Paul

AU - Gasse, Christiane

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KW - European Medicines Agency

KW - Innovative Medicines Initiative

KW - Methodology

KW - Observational studies

KW - Pharmacoepidemiology

KW - PROTECT

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AN - SCOPUS:84962878589

SN - 1053-8569

VL - 25

SP - 5

EP - 10

JO - Pharmacoepidemiology and Drug Safety

JF - Pharmacoepidemiology and Drug Safety

IS - suppl 51

ER -

The IMI PROTECT project: Purpose, organizational structure, and procedures

Abstract

Keywords

UN SDGs

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