Title |
Good Signal Detection Practices: Evidence from IMI PROTECT
|
---|---|
Published in |
Drug Safety, March 2016
|
DOI | 10.1007/s40264-016-0405-1 |
Pubmed ID | |
Authors |
Antoni F. Z. Wisniewski, Andrew Bate, Cedric Bousquet, Andreas Brueckner, Gianmario Candore, Kristina Juhlin, Miguel A. Macia-Martinez, Katrin Manlik, Naashika Quarcoo, Suzie Seabroke, Jim Slattery, Harry Southworth, Bharat Thakrar, Phil Tregunno, Lionel Van Holle, Michael Kayser, G. Niklas Norén |
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. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
India | 1 | 17% |
Switzerland | 1 | 17% |
New Zealand | 1 | 17% |
Unknown | 3 | 50% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 4 | 67% |
Scientists | 1 | 17% |
Science communicators (journalists, bloggers, editors) | 1 | 17% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 113 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Ph. D. Student | 26 | 23% |
Student > Master | 19 | 17% |
Researcher | 18 | 16% |
Other | 6 | 5% |
Student > Bachelor | 5 | 4% |
Other | 11 | 10% |
Unknown | 28 | 25% |
Readers by discipline | Count | As % |
---|---|---|
Pharmacology, Toxicology and Pharmaceutical Science | 26 | 23% |
Medicine and Dentistry | 25 | 22% |
Computer Science | 6 | 5% |
Nursing and Health Professions | 5 | 4% |
Social Sciences | 3 | 3% |
Other | 10 | 9% |
Unknown | 38 | 34% |