5 papers
SHIELD: Semantic Heterogeneity Integrated Embedding for Latent Discovery in Clinical Trial Safety Signals
Francois Vandenhende, Anna Georgiou, Theodoros Psaras +1
We present SHIELD, a novel methodology for automated and integrated safety signal detection in clinical trials. SHIELD combines disproportionality analysis with semantic clustering…
Automated Generation of Custom MedDRA Queries Using SafeTerm Medical Map
Francois Vandenhende, Anna Georgiou, Michalis Georgiou +3
In pre-market drug safety review, grouping related adverse event terms into standardised MedDRA queries or the FDA Office of New Drugs Custom Medical Queries (OCMQs) is critical fo…
Performance of the SafeTerm AI-Based MedDRA Query System Against Standardised MedDRA Queries
Francois Vandenhende, Anna Georgiou, Michalis Georgiou +3
In pre-market drug safety review, grouping related adverse event terms into SMQs or OCMQs is critical for signal detection. We assess the performance of SafeTerm Automated Medical…
Automated PRO-CTCAE Symptom Selection based on Prior Adverse Event Profiles
Francois Vandenhende, Anna Georgiou, Michalis Georgiou +2
The PRO-CTCAE is an NCI-developed patient-reported outcome system for capturing symptomatic adverse events in oncology trials. It comprises a large library drawn from the CTCAE voc…
Knowledge-based Graphical Method for Safety Signal Detection in Clinical Trials
Francois Vandenhende, Anna Georgiou, Michalis Georgiou +3
We present a graphical, knowledge-based method for reviewing treatment-emergent adverse events (AEs) in clinical trials. The approach enhances MedDRA by adding a hidden medical kno…