The IMI PROTECT project: purpose, organizational structure, and procedures
| Autor: | Luisa Ibáñez, Stéphanie Tcherny-Lessenot, Mark De Groot, Belen Oliva, Christiane Gasse, Toine Egberts, Ruth Brauer, Frank De Vries, Consuelo Huerta, Helga Gardarsdottir, Marie Louise (Marieke) De Bruin, Juhaeri Juhaeri, Francisco Jose De Abajo Iglesias, Tjeerd Van Staa, Lamiae Grimaldi-Bensouda |
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| Rok vydání: | 2016 |
| Předmět: |
Knowledge management
Epidemiology business.industry Pharmacoepidemiology 030226 pharmacology & pharmacy 03 medical and health sciences 0302 clinical medicine Pharmacovigilance Health care Medicine media_common.cataloged_instance Pharmacology (medical) Observational study Organizational structure 030212 general & internal medicine Small and medium-sized enterprises European union business Pharmaceutical industry media_common |
| Zdroj: | Pharmacoepidemiology and Drug Safety. 25:5-10 |
| ISSN: | 1053-8569 |
| DOI: | 10.1002/pds.3933 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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