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Good Signal Detection Practices: Evidence from IMI PROTECT

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

in Clinical trials / Confidence intervals / Conflicts of interest / Consortia / Drug Safety and Pharmacovigilance / Expected values / Medicine / Medicine & Public Health / Pharmaceutical industry / Pharmacology/Toxicology / Special / Special Article / Stockholders

2016

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2016

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2016

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Journal Article

Good Signal Detection Practices: Evidence from IMI PROTECT

Wisniewski, Antoni F. Z.,

Kayser, Michael,

Quarcoo, Naashika,

Thakrar, Bharat,

Brueckner, Andreas,

Slattery, Jim,

Manlik, Katrin,

Candore, Gianmario,

Norén, G. Niklas,

Bousquet, Cedric,

Tregunno, Phil,

Van Holle, Lionel,

Bate, Andrew,

Juhlin, Kristina,

Seabroke, Suzie,

Southworth, Harry,

Macia-Martinez, Miguel A.

2016

Overview

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.

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Publisher

Springer International Publishing,Springer Nature B.V

Subject

Clinical trials

/ Confidence intervals

/ Conflicts of interest

/ Consortia

/ Drug Safety and Pharmacovigilance

/ Expected values

/ Medicine