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2016 ; 39
(6
): 469-90
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gab.com Text
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English Wikipedia
Good Signal Detection Practices: Evidence from IMI PROTECT
#MMPMID26951233
Wisniewski AF
; Bate A
; Bousquet C
; Brueckner A
; Candore G
; Juhlin K
; Macia-Martinez MA
; Manlik K
; Quarcoo N
; Seabroke S
; Slattery J
; Southworth H
; Thakrar B
; Tregunno P
; Van Holle L
; Kayser M
; Norén GN
Drug Saf
2016[Jun]; 39
(6
): 469-90
PMID26951233
show ga
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.
|Adverse Drug Reaction Reporting Systems/*standards
[MESH]
|Databases, Factual/*standards
[MESH]
|Drug-Related Side Effects and Adverse Reactions/*epidemiology
[MESH]