Using the internet to enhance drug safety monitoring from phase 1 to phase 4 in dermatology clinical trials

2004 ◽  
Vol 50 (3) ◽  
pp. P82
Author(s):  
Jules T. Mitchel ◽  
Otto Mills
Keyword(s):  
Clinical Trials ◽  
Drug Safety ◽  
Phase 1 ◽  
Safety Monitoring ◽  
The Internet ◽  
Drug Safety Monitoring

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.

Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project

2010 ◽  
Vol 20 (1) ◽  
pp. 1-11 ◽  
Author(s):  
Preciosa M. Coloma ◽  
Martijn J. Schuemie ◽  
Gianluca Trifirò ◽  
Rosa Gini ◽  
Ron Herings ◽  
...  
Keyword(s):  
Drug Safety ◽  
Large Scale ◽  
Safety Monitoring ◽  
Electronic Healthcare Databases ◽  
Drug Safety Monitoring ◽  
The Eu

scholarly journals PHP2 Relation Between Consumer Behaviour and Drug Safety Monitoring in France

2011 ◽  
Vol 14 (7) ◽  
pp. A333
Author(s):  
J. Furet ◽  
C. Genane ◽  
G. Ando ◽  
G. Marinoni
Keyword(s):  
Drug Safety ◽  
Consumer Behaviour ◽  
Safety Monitoring ◽  
Drug Safety Monitoring

scholarly journals Drug Safety Monitoring in Children: Performance of Signal Detection Algorithms and Impact of Age Stratification

Drug Safety ◽  
2016 ◽  
Vol 39 (9) ◽  
pp. 873-881 ◽  
Author(s):  
Osemeke U. Osokogu ◽  
Caitlin Dodd ◽  
Alexandra Pacurariu ◽  
Florentia Kaguelidou ◽  
Daniel Weibel ◽  
...  
Keyword(s):  
Signal Detection ◽  
Drug Safety ◽  
Safety Monitoring ◽  
Detection Algorithms ◽  
Drug Safety Monitoring ◽  
Age Stratification

scholarly journals Drug Safety Monitoring—International Information

2020 ◽  
Vol 8 (4) ◽  
pp. 211-213
Author(s):  
E. V. Shubnikova ◽  
T. M. Bukatina ◽  
G. V. Kutekhova
Keyword(s):  
Drug Safety ◽  
Patient Information ◽  
Safety Monitoring ◽  
Expert Evaluation ◽  
Medicinal Products ◽  
Patient Information Leaflets ◽  
Regulatory Authorities ◽  
Information Leaflets ◽  
Drug Safety Monitoring

Experts of the Department for Evaluation of Medicinal Products’ Safety of the Scientific Centre for Expert Evaluation of Medicinal Products analysed administrative decisions of foreign regulatory authorities on limiting the use of some medicinal products and/or the need to introduce changes in patient information leaflets due to changes in the medicines’ safety profiles. The analysis helped to identify 16 administrative decisions that contain information on the following medicines registered in Russia: duloxetine, sertraline, paroxetine, сitalopram, desvenlafaxine, escitalopram, fluoxetine, fluvoxamine, milnacipran, paroxetine, venlafaxine, vortioxetine, mirtazapine, risperidone, clozapine, aripiprazole, quetiapine, olanzapine, lacosamide, gabapentin, pregabalin. 

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