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.
authors.affiliation: Epidemiology, Pfizer, New York, NY, USA.
authors.forename: Robert F
authors.initials: RF
authors.lastname: Reynolds
authors.affiliation: European Medicines Agency (EMA), London, UK.
authors.forename: Xavier
authors.initials: X
authors.lastname: Kurz
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, the Netherlands.|Department of Clinical Chemistry and Haematology, Division of Laboratory and Pharmacy, University Medical Center Utrecht, Utrecht, the Netherlands.
authors.forename: Mark C H
authors.identifier: http://orcid.org/0000-0002-5764-5788
authors.initials: MC
authors.lastname: de Groot
authors.affiliation: Quantitative Safety and Epidemiology, Novartis Pharma AG, Basel, Switzerland.
authors.forename: Raymond G
authors.initials: RG
authors.lastname: Schlienger
authors.affiliation: LA-SER and Pasteur Institute (Pharmacoepidemiology and Infectious diseases Unit), Paris, France.
authors.forename: Lamiae
authors.initials: L
authors.lastname: Grimaldi-Bensouda
authors.affiliation: Global Pharmacovigilance and Epidemiology, Sanofi, Chilly-Mazarin, France.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Tcherny-Lessenot
authors.affiliation: Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, the Netherlands.|Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht, the Netherlands.
authors.forename: Olaf H
authors.initials: OH
authors.lastname: Klungel
mesh_terms: D004345:Drug Industry / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D006801:Humans; D017891:Pharmacoepidemiology
keywords: European Medicines Agency; Innovative Medicines Initiative; PROTECT; electronic healthcare databases; methodology; observational studies; pharmacoepidemiology