The IMI PROTECT project: purpose, organizational structure, and procedures.
Pharmacoepidemiol Drug Saf
; 25 Suppl 1: 5-10, 2016 Mar.
Article
em En
| MEDLINE
| ID: mdl-27038353
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.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Farmacoepidemiologia
/
Indústria Farmacêutica
/
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
/
União Europeia
Tipo de estudo:
Observational_studies
Limite:
Humans
Idioma:
En
Revista:
Pharmacoepidemiol Drug Saf
Assunto da revista:
EPIDEMIOLOGIA
/
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
Estados Unidos