Format

Send to

Choose Destination
Drug Saf. 2016 Jun;39(6):469-90. doi: 10.1007/s40264-016-0405-1.

Good Signal Detection Practices: Evidence from IMI PROTECT.

Author information

1
AstraZeneca, Macclesfield, UK. antoni.wisniewski@astrazeneca.com.
2
Pfizer, Walton-on-the-Hill, Surrey, UK.
3
INSERM, UMR_S1142, LIMICS, Paris, France.
4
Department of Public Health and Medical Informatics, CHU University Hospital of Saint Etienne, Saint-Étienne, France.
5
Novartis, Basel, Switzerland.
6
European Medicines Agency, London, UK.
7
Uppsala Monitoring Centre, Uppsala, Sweden.
8
Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
9
Bayer Pharma AG, Berlin, Germany.
10
GlaxoSmithKline, London, UK.
11
Medicines and Healthcare Products Regulatory Agency, London, UK.
12
Data Clarity Consulting, Stockport, UK.
13
F. Hoffmann-La Roche, Basel, Switzerland.
14
GlaxoSmithKline, Wavre, Belgium.
15
Bayer Pharma AG, Wuppertal, Germany.

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.

PMID:
26951233
PMCID:
PMC4871909
DOI:
10.1007/s40264-016-0405-1
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Springer Icon for PubMed Central
Loading ...
Support Center