title: Good Signal Detection Practices: Evidence from IMI PROTECT.
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.
authors.affiliation: AstraZeneca, Macclesfield, UK. antoni.wisniewski@astrazeneca.com.
authors.forename: Antoni F Z
authors.identifier: 0000-0002-0536-5514
authors.initials: AF
authors.lastname: Wisniewski
authors.affiliation: Pfizer, Walton-on-the-Hill, Surrey, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Bate
authors.affiliation: INSERM, UMR_S1142, LIMICS, Paris, France.|Department of Public Health and Medical Informatics, CHU University Hospital of Saint Etienne, Saint-Étienne, France.
authors.forename: Cedric
authors.initials: C
authors.lastname: Bousquet
authors.affiliation: Novartis, Basel, Switzerland.
authors.forename: Andreas
authors.initials: A
authors.lastname: Brueckner
authors.affiliation: European Medicines Agency, London, UK.
authors.forename: Gianmario
authors.initials: G
authors.lastname: Candore
authors.affiliation: Uppsala Monitoring Centre, Uppsala, Sweden.
authors.forename: Kristina
authors.initials: K
authors.lastname: Juhlin
authors.affiliation: Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Macia-Martinez
authors.affiliation: Bayer Pharma AG, Berlin, Germany.
authors.forename: Katrin
authors.initials: K
authors.lastname: Manlik
authors.affiliation: GlaxoSmithKline, London, UK.
authors.forename: Naashika
authors.initials: N
authors.lastname: Quarcoo
authors.affiliation: Medicines and Healthcare Products Regulatory Agency, London, UK.
authors.forename: Suzie
authors.initials: S
authors.lastname: Seabroke
authors.affiliation: European Medicines Agency, London, UK.
authors.forename: Jim
authors.initials: J
authors.lastname: Slattery
authors.affiliation: Data Clarity Consulting, Stockport, UK.
authors.forename: Harry
authors.initials: H
authors.lastname: Southworth
authors.affiliation: F. Hoffmann-La Roche, Basel, Switzerland.
authors.forename: Bharat
authors.initials: B
authors.lastname: Thakrar
authors.affiliation: Medicines and Healthcare Products Regulatory Agency, London, UK.
authors.forename: Phil
authors.initials: P
authors.lastname: Tregunno
authors.affiliation: GlaxoSmithKline, Wavre, Belgium.
authors.forename: Lionel
authors.initials: L
authors.lastname: Van Holle
authors.affiliation: Bayer Pharma AG, Wuppertal, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Kayser
authors.affiliation: Uppsala Monitoring Centre, Uppsala, Sweden.
authors.forename: G Niklas
authors.initials: GN
authors.lastname: Norén
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D016208:Databases, Factual / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005060:Europe; D006801:Humans; D060735:Pharmacovigilance; D058996:Quality Improvement