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 int...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Wisniewski, Antoni F. Z. [verfasserIn] Bate, Andrew [verfasserIn] Bousquet, Cedric [verfasserIn] Brueckner, Andreas [verfasserIn] Candore, Gianmario [verfasserIn] Juhlin, Kristina [verfasserIn] Macia-Martinez, Miguel A. [verfasserIn] Manlik, Katrin [verfasserIn] Quarcoo, Naashika [verfasserIn] Seabroke, Suzie [verfasserIn] Slattery, Jim [verfasserIn] Southworth, Harry [verfasserIn] Thakrar, Bharat [verfasserIn] Tregunno, Phil [verfasserIn] Van Holle, Lionel [verfasserIn] Kayser, Michael [verfasserIn] Norén, G. Niklas [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2016 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: Drug safety - Berlin [u.a.] : Springer, 1990, 39(2016), 6 vom: 07. März, Seite 469-490 |
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| Übergeordnetes Werk: |
volume:39 ; year:2016 ; number:6 ; day:07 ; month:03 ; pages:469-490 |
| Links: |
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| DOI / URN: |
10.1007/s40264-016-0405-1 |
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| Katalog-ID: |
SPR033124841 |
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| 520 | |a 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. | ||
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| 700 | 1 | |a Bousquet, Cedric |e verfasserin |4 aut | |
| 700 | 1 | |a Brueckner, Andreas |e verfasserin |4 aut | |
| 700 | 1 | |a Candore, Gianmario |e verfasserin |4 aut | |
| 700 | 1 | |a Juhlin, Kristina |e verfasserin |4 aut | |
| 700 | 1 | |a Macia-Martinez, Miguel A. |e verfasserin |4 aut | |
| 700 | 1 | |a Manlik, Katrin |e verfasserin |4 aut | |
| 700 | 1 | |a Quarcoo, Naashika |e verfasserin |4 aut | |
| 700 | 1 | |a Seabroke, Suzie |e verfasserin |4 aut | |
| 700 | 1 | |a Slattery, Jim |e verfasserin |4 aut | |
| 700 | 1 | |a Southworth, Harry |e verfasserin |4 aut | |
| 700 | 1 | |a Thakrar, Bharat |e verfasserin |4 aut | |
| 700 | 1 | |a Tregunno, Phil |e verfasserin |4 aut | |
| 700 | 1 | |a Van Holle, Lionel |e verfasserin |4 aut | |
| 700 | 1 | |a Kayser, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Norén, G. Niklas |e verfasserin |4 aut | |
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10.1007/s40264-016-0405-1 doi (DE-627)SPR033124841 (SPR)s40264-016-0405-1-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Wisniewski, Antoni F. Z. verfasserin aut Good Signal Detection Practices: Evidence from IMI PROTECT 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Signal Detection (dpeaa)DE-He213 Quantitative Signal Detection (dpeaa)DE-He213 Proportional Reporting Ratio (dpeaa)DE-He213 Observational Medical Outcome Partnership (dpeaa)DE-He213 Uppsala Monitoring Centre (dpeaa)DE-He213 Bate, Andrew verfasserin aut Bousquet, Cedric verfasserin aut Brueckner, Andreas verfasserin aut Candore, Gianmario verfasserin aut Juhlin, Kristina verfasserin aut Macia-Martinez, Miguel A. verfasserin aut Manlik, Katrin verfasserin aut Quarcoo, Naashika verfasserin aut Seabroke, Suzie verfasserin aut Slattery, Jim verfasserin aut Southworth, Harry verfasserin aut Thakrar, Bharat verfasserin aut Tregunno, Phil verfasserin aut Van Holle, Lionel verfasserin aut Kayser, Michael verfasserin aut Norén, G. Niklas verfasserin aut Enthalten in Drug safety Berlin [u.a.] : Springer, 1990 39(2016), 6 vom: 07. März, Seite 469-490 (DE-627)320630714 (DE-600)2023894-0 1179-1942 nnns volume:39 year:2016 number:6 day:07 month:03 pages:469-490 https://dx.doi.org/10.1007/s40264-016-0405-1 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 ASE AR 39 2016 6 07 03 469-490 |
| spelling |
10.1007/s40264-016-0405-1 doi (DE-627)SPR033124841 (SPR)s40264-016-0405-1-e DE-627 ger DE-627 rakwb eng 610 ASE 44.40 bkl Wisniewski, Antoni F. Z. verfasserin aut Good Signal Detection Practices: Evidence from IMI PROTECT 2016 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Signal Detection (dpeaa)DE-He213 Quantitative Signal Detection (dpeaa)DE-He213 Proportional Reporting Ratio (dpeaa)DE-He213 Observational Medical Outcome Partnership (dpeaa)DE-He213 Uppsala Monitoring Centre (dpeaa)DE-He213 Bate, Andrew verfasserin aut Bousquet, Cedric verfasserin aut Brueckner, Andreas verfasserin aut Candore, Gianmario verfasserin aut Juhlin, Kristina verfasserin aut Macia-Martinez, Miguel A. verfasserin aut Manlik, Katrin verfasserin aut Quarcoo, Naashika verfasserin aut Seabroke, Suzie verfasserin aut Slattery, Jim verfasserin aut Southworth, Harry verfasserin aut Thakrar, Bharat verfasserin aut Tregunno, Phil verfasserin aut Van Holle, Lionel verfasserin aut Kayser, Michael verfasserin aut Norén, G. Niklas verfasserin aut Enthalten in Drug safety Berlin [u.a.] : Springer, 1990 39(2016), 6 vom: 07. März, Seite 469-490 (DE-627)320630714 (DE-600)2023894-0 1179-1942 nnns volume:39 year:2016 number:6 day:07 month:03 pages:469-490 https://dx.doi.org/10.1007/s40264-016-0405-1 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA SSG-OPC-PHA SSG-OPC-ASE GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.40 ASE AR 39 2016 6 07 03 469-490 |
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Enthalten in Drug safety 39(2016), 6 vom: 07. März, Seite 469-490 volume:39 year:2016 number:6 day:07 month:03 pages:469-490 |
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Signal Detection Quantitative Signal Detection Proportional Reporting Ratio Observational Medical Outcome Partnership Uppsala Monitoring Centre |
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Wisniewski, Antoni F. Z. @@aut@@ Bate, Andrew @@aut@@ Bousquet, Cedric @@aut@@ Brueckner, Andreas @@aut@@ Candore, Gianmario @@aut@@ Juhlin, Kristina @@aut@@ Macia-Martinez, Miguel A. @@aut@@ Manlik, Katrin @@aut@@ Quarcoo, Naashika @@aut@@ Seabroke, Suzie @@aut@@ Slattery, Jim @@aut@@ Southworth, Harry @@aut@@ Thakrar, Bharat @@aut@@ Tregunno, Phil @@aut@@ Van Holle, Lionel @@aut@@ Kayser, Michael @@aut@@ Norén, G. Niklas @@aut@@ |
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Wisniewski, Antoni F. Z. |
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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 |
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Good Signal Detection Practices: Evidence from IMI PROTECT |
| abstract |
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. |
| abstractGer |
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. |
| abstract_unstemmed |
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. |
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| container_issue |
6 |
| title_short |
Good Signal Detection Practices: Evidence from IMI PROTECT |
| url |
https://dx.doi.org/10.1007/s40264-016-0405-1 |
| remote_bool |
true |
| author2 |
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 |
| author2Str |
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 |
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| doi_str |
10.1007/s40264-016-0405-1 |
| up_date |
2024-07-03T16:47:29.871Z |
| _version_ |
1803577196410830848 |
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| score |
7.4018593 |