Good Signal Detection Practices: Evidence from IMI PROTECT.
Drug Saf
; 39(6): 469-90, 2016 06.
Article
en En
| MEDLINE
| ID: mdl-26951233
ABSTRACT
Over a period of 5 years, the Innovative Medicines Initiative PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) project has addressed key research questions relevant to the science of safety signal detection. The results of studies conducted into quantitative signal detection in spontaneous reporting, clinical trial and electronic health records databases are summarised and 39 recommendations have been formulated, many based on comparative analyses across a range of databases (e.g. regulatory, pharmaceutical company). The recommendations point to pragmatic steps that those working in the pharmacovigilance community can take to improve signal detection practices, whether in a national or international agency or in a pharmaceutical company setting. PROTECT has also pointed to areas of potentially fruitful future research and some areas where further effort is likely to yield less.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Bases de Datos Factuales
/
Sistemas de Registro de Reacción Adversa a Medicamentos
/
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos
Tipo de estudio:
Diagnostic_studies
/
Guideline
Límite:
Humans
País/Región como asunto:
Europa
Idioma:
En
Revista:
Drug Saf
Asunto de la revista:
TERAPIA POR MEDICAMENTOS
/
TOXICOLOGIA
Año:
2016
Tipo del documento:
Article
País de afiliación:
Reino Unido