This project illustrates how we help pharmaceutical and healthcare organizations identify potential safety signals and evaluate comparative drug risks using real-world pharmacovigilance data.
Pharmaceutical manufacturers, regulatory stakeholders, and healthcare organizations seeking to understand the safety profiles of GLP-1 receptor agonists using post-marketing surveillance data.
GLP-1 therapies have experienced rapid adoption for the treatment of diabetes and obesity. As utilization increased, questions emerged regarding the relative safety profiles of different products within the class.
Stakeholders required a systematic approach to:
- Evaluate adverse event patterns across therapies
- Identify potential safety signals requiring further investigation
- Understand demographic differences in reporting
- Support evidence-based pharmacovigilance and risk management activities
- Analyze post-marketing safety data from FAERS
- Compare adverse event reporting across GLP-1 therapies
- Quantify reporting disproportionality using signal detection methods
- Evaluate reporting patterns by age and sex
- Generate decision-ready insights for safety monitoring
FAERS Data Integration
Collected and standardized adverse event reports for five GLP-1 therapies.
Signal Detection Analysis
Performed disproportionality analysis using Reporting Odds Ratios (RORs) to evaluate potential safety signals across key adverse events.
Demographic Assessment
Analyzed reporting patterns by age and sex to identify population-specific trends.
Comparative Safety Evaluation
Developed visualizations and comparative analyses to support pharmacovigilance decision-making and safety monitoring.
- Identified potential safety signals requiring further clinical evaluation
- Quantified comparative reporting patterns across five GLP-1 therapies
- Highlighted demographic differences in adverse event reporting
- Demonstrated the application of FAERS data for signal detection and risk assessment
- Provided a scalable framework for ongoing pharmacovigilance surveillance and regulatory monitoring
Real-world pharmacovigilance data can reveal clinically relevant safety patterns that may not be fully apparent during pre-approval clinical trials, enabling earlier detection of emerging risks and more informed risk-benefit assessments.
The project demonstrated how post-marketing surveillance and disproportionality analysis can support pharmacovigilance activities, signal detection, and comparative safety evaluation across therapies within the same drug class. The methodology can be adapted to other therapeutic areas and regulatory safety monitoring initiatives.