scholarly journals Pediatric Drug Safety Signal Detection: A New Drug–Event Reference Set for Performance Testing of Data-Mining Methods and Systems

Drug Safety ◽  
2015 ◽  
Vol 38 (2) ◽  
pp. 207-217 ◽  
Author(s):  
Osemeke U. Osokogu ◽  
Federica Fregonese ◽  
Carmen Ferrajolo ◽  
Katia Verhamme ◽  
Sandra de Bie ◽  
...  
Keyword(s):  
Data Mining ◽  
Signal Detection ◽  
Drug Safety ◽  
Performance Testing ◽  
Drug Event ◽  
Safety Signal ◽  
Pediatric Drug ◽  
New Drug ◽  
Reference Set ◽  
Mining Methods

Masking by vaccines in pediatric drug safety signal detection in the EudraVigilance database

2018 ◽  
Vol 27 (11) ◽  
pp. 1249-1256 ◽  
Author(s):  
Caitlin Dodd ◽  
Alexandra Pacurariu ◽  
Osemeke U. Osokogu ◽  
Daniel Weibel ◽  
Carmen Ferrajolo ◽  
...  
Keyword(s):  
Signal Detection ◽  
Drug Safety ◽  
Safety Signal ◽  
Pediatric Drug

Reference set for performance testing of pediatric vaccine safety signal detection methods and systems

Vaccine ◽  
2016 ◽  
Vol 34 (51) ◽  
pp. 6626-6633 ◽  
Author(s):  
Yolanda Brauchli Pernus ◽  
Cassandra Nan ◽  
Thomas Verstraeten ◽  
Mariia Pedenko ◽  
Osemeke U. Osokogu ◽  
...  
Keyword(s):  
Signal Detection ◽  
Performance Testing ◽  
Vaccine Safety ◽  
Detection Methods ◽  
Safety Signal ◽  
Reference Set

Pediatric drug safety signal detection of non-chemotherapy drug-induced neutropenia and agranulocytosis using electronic healthcare records

2019 ◽  
Vol 18 (5) ◽  
pp. 435-441 ◽  
Author(s):  
Ran Wei ◽  
Lu-Lu Jia ◽  
Yun-Cui Yu ◽  
Xiao-Lu Nie ◽  
Zi-Yang Song ◽  
...  
Keyword(s):  
Signal Detection ◽  
Drug Safety ◽  
Safety Signal ◽  
Pediatric Drug ◽  
Drug Induced ◽  
Chemotherapy Drug

scholarly journals Harnessing scientific literature reports for pharmacovigilance

2017 ◽  
Vol 26 (01) ◽  
pp. 291-305
Author(s):  
Alfred Sorbello ◽  
Anna Ripple ◽  
Joseph Tonning ◽  
Monica Munoz ◽  
Rashedul Hasan ◽  
...  
Keyword(s):  
Data Mining ◽  
Adverse Event ◽  
Signal Detection ◽  
User Satisfaction ◽  
Scientific Literature ◽  
Usability Testing ◽  
Analytical Tool ◽  
Drug Event ◽  
Safety Signal ◽  
Safety Signals

Summary Objectives: We seek to develop a prototype software analytical tool to augment FDA regulatory reviewers’ capacity to harness scientific literature reports in PubMed/MEDLINE for pharmacovigilance and adverse drug event (ADE) safety signal detection. We also aim to gather feedback through usability testing to assess design, performance, and user satisfaction with the tool. Methods: A prototype, open source, web-based, software analytical tool generated statistical disproportionality data mining signal scores and dynamic visual analytics for ADE safety signal detection and management. We leveraged Medical Subject Heading (MeSH) indexing terms assigned to published citations in PubMed/MEDLINE to generate candidate drug-adverse event pairs for quantitative data mining. Six FDA regulatory reviewers participated in usability testing by employing the tool as part of their ongoing real-life pharmacovigilance activities to provide subjective feedback on its practical impact, added value, and fitness for use. Results: All usability test participants cited the tool’s ease of learning, ease of use, and generation of quantitative ADE safety signals, some of which corresponded to known established adverse drug reactions. Potential concerns included the comparability of the tool’s automated literature search relative to a manual ‘all fields’ PubMed search, missing drugs and adverse event terms, interpretation of signal scores, and integration with existing computer-based analytical tools. Conclusions: Usability testing demonstrated that this novel tool can automate the detection of ADE safety signals from published literature reports. Various mitigation strategies are described to foster improvements in design, productivity, and end user satisfaction.

Evaluating performance of electronic healthcare records and spontaneous reporting data in drug safety signal detection

2014 ◽  
Vol 37 (1) ◽  
pp. 94-104 ◽  
Author(s):  
Vaishali K. Patadia ◽  
Martijn J. Schuemie ◽  
Preciosa Coloma ◽  
Ron Herings ◽  
Johan van der Lei ◽  
...  
Keyword(s):  
Signal Detection ◽  
Drug Safety ◽  
Spontaneous Reporting ◽  
Safety Signal ◽  
Reporting Data

A Reference Standard for Evaluation of Methods for Drug Safety Signal Detection Using Electronic Healthcare Record Databases

Drug Safety ◽  
2012 ◽  
Vol 36 (1) ◽  
pp. 13-23 ◽  
Author(s):  
Preciosa M. Coloma ◽  
Paul Avillach ◽  
Francesco Salvo ◽  
Martijn J. Schuemie ◽  
Carmen Ferrajolo ◽  
...  
Keyword(s):  
Signal Detection ◽  
Drug Safety ◽  
Safety Signal ◽  
Reference Standard ◽  
Electronic Healthcare Record ◽  
Evaluation Of Methods

scholarly journals An MCEM Framework for Drug Safety Signal Detection and Combination from Heterogeneous Real World Evidence

2018 ◽  
Vol 8 (1) ◽  
Author(s):  
Cao Xiao ◽  
Ying Li ◽  
Inci M. Baytas ◽  
Jiayu Zhou ◽  
Fei Wang
Keyword(s):  
Signal Detection ◽  
Drug Safety ◽  
Real World ◽  
Safety Signal ◽  
Real World Evidence

Data Mining Methods for Signal Detection

2021 ◽  
pp. 11-30
Author(s):  
Ram Tiwari ◽  
Jyoti Zalkikar ◽  
Lan Huang
Keyword(s):  
Data Mining ◽  
Signal Detection ◽  
Mining Methods
Sign in / Sign up

Export Citation Format

Share Document