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

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

Safety Signal Detection in the Drug Development Process

2015 ◽  
pp. 64-89
Author(s):  
Ramin B. Arani ◽  
Antoni F.Z. Wisniewski
Keyword(s):  
Adverse Event ◽  
Drug Development ◽  
Signal Detection ◽  
Safety Information ◽  
Safety Signal ◽  
Drug Development Process ◽  
Safety And Efficacy ◽  
Strength Of Association ◽  
Efficacy Profile ◽  
Complicated Task

Drug development is a complex set of inter-linked processes in which the cumulative understanding of a drug's safety and efficacy profile is shaped during different learning phases. Often, drugs are approved based on limited safety information, for example in highly at risk or rare disease populations. Therefore, post approval, regulatory organizations have mandated proactive surveillance strategies that include the collection of reported adverse events experienced by exposed populations, some of whom may have been on treatment for extended periods of time. Analyzing these accumulating adverse event reports to understand their clinical significance, given the limitations imposed by the methods of data collection, is a complicated task. The aim of this chapter is to provide the readers with a general understanding of safety signal detection and assessment, followed by a description of statistical methods (both classical and Bayesian) typically utilized for quantifying the strength of association between a drug and an adverse event.

Signal detection of adverse events with imperfect confirmation rates in vaccine safety studies using self-controlled case series design

2014 ◽  
Vol 56 (3) ◽  
pp. 513-525 ◽  
Author(s):  
Stanley Xu ◽  
Sophia Newcomer ◽  
Jennifer Nelson ◽  
Lei Qian ◽  
David McClure ◽  
...  
Keyword(s):  
Adverse Events ◽  
Signal Detection ◽  
Case Series ◽  
Vaccine Safety ◽  
Series Design ◽  
Safety Studies

Bayesian hierarchical model for safety signal detection in multiple clinical trials

2020 ◽  
Vol 99 ◽  
pp. 106183
Author(s):  
Yafei Zhang ◽  
Shuai Sammy Yuan ◽  
Barry A. Eagel ◽  
Hal Li ◽  
Li-An Lin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Signal Detection ◽  
Hierarchical Model ◽  
Bayesian Hierarchical Model ◽  
Safety Signal ◽  
Bayesian Hierarchical
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