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; Stephanie Tcherny-Lessenot; Olaf H. Klungel; Y. Alvarez; G. Candore; J. Durand; J. Slattery; J. Hasford; M. Rottenkolber; S. Schmiedl; F. de Abajo Iglesias; M. Gil; R. Gonzalez; C. Huerta Alvarez; E. Martin; B. Oliva; G. Requena; J. Amelio; R. Brauer; G. Downey; M. Feudjo-Tepie; M. Schoonen; S. Johansson; J. Robinson; M. Schuerch; I. Tatt; L. A. Garcia; A. Ruigomez; J. Campbell; A. Gallagher; E. Ng; T. P. van Staa; O. Demol; N. Boudiaf; K. Davis; J. Logie; J. Pimenta; R. Beau-Lejdstrom; L. Abenhaim; M. Rossignol; U. Hesse; P. F. Rønn; M. Miret; J. Fortuny; P. Primatesta; E. Rivero; R. Schlienger; A. Bate; N. Gatto; E. Ballarin; P. Ferrer; L. Ibañez; J. R. Laporte; M. Sabaté; V. Abbing-Karahagopian; S. Ali; D. de Bakker; S. Belitser; A. de Boer; M. L. De Bruin; A. C.G. Egberts; L. van Dijk; H. Gardarsdottir; R. H. Groenwold; A. W. Hoes; H. G.M. Leufkens; W. Pestman; K. C.B. Roes; P. Souverein; F. Rutten; J. Uddin; H. A. van den Ham; E. Voogd; F. de Vries; R. Udo; L. Auclert; J. Juhaeri; L. Mazuranok; L. Wise; D. Irvine; P. Dolin; C. 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
, Stephanie Tcherny-Lessenot
, Olaf H. Klungel
, Y. Alvarez
, G. Candore
, J. Durand
, J. Slattery
, J. Hasford
, M. Rottenkolber
, S. Schmiedl
, F. de Abajo Iglesias
, M. Gil
, R. Gonzalez
, C. Huerta Alvarez
, E. Martin
, B. Oliva

G. Requena, J. Amelio, R. Brauer, G. Downey, M. Feudjo-Tepie, M. Schoonen, S. Johansson, J. Robinson, M. Schuerch, I. Tatt, L. A. Garcia, A. Ruigomez, J. Campbell, A. Gallagher, E. Ng, T. P. van Staa, O. Demol, N. Boudiaf, K. Davis, J. Logie, J. Pimenta, R. Beau-Lejdstrom, L. Abenhaim, M. Rossignol, U. Hesse, P. F. Rønn, M. Miret, J. Fortuny, P. Primatesta, E. Rivero, R. Schlienger, A. Bate, N. Gatto, E. Ballarin, P. Ferrer, L. Ibañez, J. R. Laporte, M. Sabaté, V. Abbing-Karahagopian, S. Ali, D. de Bakker, S. Belitser, A. de Boer, M. L. De Bruin, A. C.G. Egberts, L. van Dijk, H. Gardarsdottir, R. H. Groenwold, A. W. Hoes, H. G.M. Leufkens, W. Pestman, K. C.B. Roes, P. Souverein, F. Rutten, J. Uddin, H. A. van den Ham, E. Voogd, F. de Vries, R. Udo, L. Auclert, J. Juhaeri, L. Mazuranok, L. Wise, D. Irvine, P. Dolin, C. Gasse

Research output: Contribution to journal › Article › peer-review

21 Scopus citations

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
Pages (from-to)	5-10
Number of pages	6
Journal	Pharmacoepidemiology and Drug Safety
Volume	25
DOIs	https://doi.org/10.1002/pds.3933
State	Published - 1 Mar 2016
Externally published	Yes

Keywords

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

Access to Document

10.1002/pds.3933

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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., Slattery, J., Hasford, J., Rottenkolber, M., Schmiedl, S., de Abajo Iglesias, F., Gil, M., Gonzalez, R., Huerta Alvarez, C., Martin, E., ... Gasse, C. (2016). The IMI PROTECT project: Purpose, organizational structure, and procedures. Pharmacoepidemiology and Drug Safety, 25, 5-10. https://doi.org/10.1002/pds.3933

@article{9fd844a71eae431bb0dac5611150fe6f,

title = "The IMI PROTECT project: Purpose, organizational structure, and procedures",

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.",

keywords = "Electronic healthcare databases, European Medicines Agency, Innovative Medicines Initiative, Methodology, Observational studies, PROTECT, Pharmacoepidemiology",

author = "Reynolds, \{Robert F.\} and Xavier Kurz and \{de Groot\}, \{Mark C.H.\} and Schlienger, \{Raymond G.\} and Lamiae Grimaldi-Bensouda and Stephanie Tcherny-Lessenot and Klungel, \{Olaf H.\} and Y. Alvarez and G. Candore and J. Durand and J. Slattery and J. Hasford and M. Rottenkolber and S. Schmiedl and \{de Abajo Iglesias\}, F. and M. Gil and R. Gonzalez and \{Huerta Alvarez\}, C. and E. Martin and B. Oliva and G. Requena and J. Amelio and R. Brauer and G. Downey and M. Feudjo-Tepie and M. Schoonen and S. Johansson and J. Robinson and M. Schuerch and I. Tatt and Garcia, \{L. A.\} and A. Ruigomez and J. Campbell and A. Gallagher and E. Ng and \{van Staa\}, \{T. P.\} and O. Demol and N. Boudiaf and K. Davis and J. Logie and J. Pimenta and R. Beau-Lejdstrom and L. Abenhaim and M. Rossignol and U. Hesse and R{\o}nn, \{P. F.\} and M. Miret and J. Fortuny and P. Primatesta and E. Rivero and R. Schlienger and A. Bate and N. Gatto and E. Ballarin and P. Ferrer and L. Iba{\~n}ez and Laporte, \{J. R.\} and M. Sabat{\'e} and V. Abbing-Karahagopian and S. Ali and \{de Bakker\}, D. and S. Belitser and \{de Boer\}, A. and \{De Bruin\}, \{M. L.\} and Egberts, \{A. C.G.\} and \{van Dijk\}, L. and H. Gardarsdottir and Groenwold, \{R. H.\} and Hoes, \{A. W.\} and Leufkens, \{H. G.M.\} and W. Pestman and Roes, \{K. C.B.\} and P. Souverein and F. Rutten and J. Uddin and \{van den Ham\}, \{H. A.\} and E. Voogd and \{de Vries\}, F. and R. Udo and L. Auclert and J. Juhaeri and L. Mazuranok and L. Wise and D. Irvine and P. Dolin and C. Gasse",

note = "Publisher Copyright: {\textcopyright} 2016 John Wiley \& Sons, Ltd.",

year = "2016",

month = mar,

day = "1",

doi = "10.1002/pds.3933",

language = "English",

volume = "25",

pages = "5--10",

journal = "Pharmacoepidemiology and Drug Safety",

issn = "1053-8569",

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Reynolds, RF, Kurz, X, de Groot, MCH, Schlienger, RG, Grimaldi-Bensouda, L, Tcherny-Lessenot, S, Klungel, OH, Alvarez, Y, Candore, G, Durand, J, Slattery, J, Hasford, J, Rottenkolber, M, Schmiedl, S, de Abajo Iglesias, F, Gil, M, Gonzalez, R, 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, J, Gallagher, A, Ng, E, 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, R, Bate, A, Gatto, N, Ballarin, E, Ferrer, P, Ibañez, L, Laporte, JR, Sabaté, M, Abbing-Karahagopian, V, Ali, S, de Bakker, D, Belitser, S, de Boer, A, De Bruin, ML, Egberts, ACG, van Dijk, L, Gardarsdottir, H, Groenwold, RH, Hoes, AW, Leufkens, HGM, Pestman, W, Roes, KCB, Souverein, P, Rutten, F, Uddin, J, van den Ham, HA, Voogd, E, de Vries, F, Udo, R, Auclert, L, Juhaeri, J, Mazuranok, L, Wise, L, Irvine, D, Dolin, P & Gasse, C 2016, 'The IMI PROTECT project: Purpose, organizational structure, and procedures', Pharmacoepidemiology and Drug Safety, vol. 25, pp. 5-10. https://doi.org/10.1002/pds.3933

TY - JOUR

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, Stephanie

AU - Klungel, Olaf H.

AU - Alvarez, Y.

AU - Candore, G.

AU - Durand, J.

AU - Slattery, J.

AU - Hasford, J.

AU - Rottenkolber, M.

AU - Schmiedl, S.

AU - de Abajo Iglesias, F.

AU - Gil, M.

AU - Gonzalez, R.

AU - Huerta Alvarez, C.

AU - Martin, E.

AU - Oliva, B.

AU - Requena, G.

AU - Amelio, J.

AU - Brauer, R.

AU - Downey, G.

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, A.

AU - Campbell, J.

AU - Gallagher, A.

AU - Ng, E.

AU - van Staa, T. P.

AU - Demol, O.

AU - Boudiaf, N.

AU - Davis, K.

AU - Logie, J.

AU - Pimenta, J.

AU - Beau-Lejdstrom, R.

AU - Abenhaim, L.

AU - Rossignol, M.

AU - Hesse, U.

AU - Rønn, P. F.

AU - Miret, M.

AU - Fortuny, J.

AU - Primatesta, P.

AU - Rivero, E.

AU - Schlienger, R.

AU - Bate, A.

AU - Gatto, N.

AU - Ballarin, E.

AU - Ferrer, P.

AU - Ibañez, L.

AU - Laporte, J. R.

AU - Sabaté, M.

AU - Abbing-Karahagopian, V.

AU - Ali, S.

AU - de Bakker, D.

AU - Belitser, S.

AU - de Boer, A.

AU - De Bruin, M. L.

AU - Egberts, A. C.G.

AU - van Dijk, L.

AU - Gardarsdottir, H.

AU - Groenwold, R. H.

AU - Hoes, A. W.

AU - Leufkens, H. G.M.

AU - Pestman, W.

AU - Roes, K. C.B.

AU - Souverein, P.

AU - Rutten, F.

AU - Uddin, J.

AU - van den Ham, H. A.

AU - Voogd, E.

AU - de Vries, F.

AU - Udo, R.

AU - Auclert, L.

AU - Juhaeri, J.

AU - Mazuranok, L.

AU - Wise, L.

AU - Irvine, D.

AU - Dolin, P.

AU - Gasse, C.

PY - 2016/3/1

Y1 - 2016/3/1

N2 - 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.

AB - 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.

KW - Electronic healthcare databases

KW - European Medicines Agency

KW - Innovative Medicines Initiative

KW - Methodology

KW - Observational studies

KW - PROTECT

KW - Pharmacoepidemiology

UR - https://www.scopus.com/pages/publications/84962878589

U2 - 10.1002/pds.3933

DO - 10.1002/pds.3933

M3 - Article

C2 - 27038353

AN - SCOPUS:84962878589

SN - 1053-8569

VL - 25

SP - 5

EP - 10

JO - Pharmacoepidemiology and Drug Safety

JF - Pharmacoepidemiology and Drug Safety

ER -

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

Abstract

Keywords

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