scholarly journals Longitudinal medical records as a complement to routine drug safety signal analysis

2015 ◽  
Vol 24 (5) ◽  
pp. 486-494 ◽  
Author(s):  
Kristina Star ◽  
Sarah Watson ◽  
Lovisa Sandberg ◽  
Jeanette Johansson ◽  
I. Ralph Edwards
Keyword(s):  
Drug Safety ◽  
Medical Records ◽  
Signal Analysis ◽  
Safety Signal

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

scholarly journals Two-stage Bayesian hierarchical modeling for blinded and unblinded safety monitoring in randomized clinical trials

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Junhao Liu ◽  
Jo Wick ◽  
Renee’ H. Martin ◽  
Caitlyn Meinzer ◽  
Dooti Roy ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Drug Safety ◽  
Safety Data ◽  
Safety Monitoring ◽  
Safety Signal ◽  
Two Stage ◽  
Bayesian Hierarchical ◽  
Potential Safety ◽  
Stage 1

Abstract Background Monitoring and reporting of drug safety during a clinical trial is essential to its success. More recent attention to drug safety has encouraged statistical methods development for monitoring and detecting potential safety signals. This paper investigates the potential impact of the process of the blinded investigator identifying a potential safety signal, which should be further investigated by the Data and Safety Monitoring Board with an unblinded safety data analysis. Methods In this paper, two-stage Bayesian hierarchical models are proposed for safety signal detection following a pre-specified set of interim analyses that are applied to efficacy. At stage 1, a hierarchical blinded model uses blinded safety data to detect a potential safety signal and at stage 2, a hierarchical logistic model is applied to confirm the signal with unblinded safety data. Results Any interim safety monitoring analysis is usually scheduled via negotiation between the trial sponsor and the Data and Safety Monitoring Board. The proposed safety monitoring process starts once 53 subjects have been enrolled into an eight-arm phase II clinical trial for the first interim analysis. Operating characteristics describing the performance of this proposed workflow are investigated using simulations based on the different scenarios. Conclusions The two-stage Bayesian safety procedure in this paper provides a statistical view to monitor safety during the clinical trials. The proposed two-stage monitoring model has an excellent accuracy of detecting and flagging a potential safety signal at stage 1, and with the most important feature that further action at stage 2 could confirm the safety issue.

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

scholarly journals A computational method to quantitatively measure pediatric drug safety using electronic medical records

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Gang Yu ◽  
Xian Zeng ◽  
Shaoqing Ni ◽  
Zheng Jia ◽  
Weihong Chen ◽  
...  
Keyword(s):  
Electronic Medical Records ◽  
Drug Safety ◽  
Medical Records ◽  
Computational Method ◽  
Pediatric Drug

scholarly journals Desloratadine and depression, a drug safety signal based on worldwide spontaneous reporting of side effects

2018 ◽  
Vol 123 (3) ◽  
pp. 174-178 ◽  
Author(s):  
Jeltje Boer ◽  
Ellen Ederveen ◽  
Birgitta Grundmark
Keyword(s):  
Side Effects ◽  
Drug Safety ◽  
Spontaneous Reporting ◽  
Safety Signal

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 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
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