Details

Autor(en) / Beteiligte

• Wisniewski, Antoni F. Z.
• Bate, Andrew
• Bousquet, Cedric
• Brueckner, Andreas
• Candore, Gianmario
• Juhlin, Kristina
• Macia-Martinez, Miguel A.
• Manlik, Katrin
• Quarcoo, Naashika
• Seabroke, Suzie
• Slattery, Jim
• Southworth, Harry
• Thakrar, Bharat
• Tregunno, Phil
• Van Holle, Lionel
• Kayser, Michael
• Norén, G. Niklas

Titel

Good Signal Detection Practices: Evidence from IMI PROTECT

Ist Teil von

• Drug safety, 2016-06, Vol.39 (6), p.469-490

Ort / Verlag

Cham: Springer International Publishing

Erscheinungsjahr

2016

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.