FAERS

FAERS analyzes post-market adverse event reports to evaluate and compare safety profiles of hepatitis C therapies using the FDA's FAERS database and Cerner health facts electronic health record data.

Key Features:

• Data Integration: Integrates spontaneous adverse event reports from FDA's FAERS (2004-2015) with medical record data from the Cerner health facts database (1999-2015).
• Statistical Procedure: Employs a three-step statistical procedure—descriptive comparison, testing for differences among groups, and quantification of association—to compare adverse events across multiple hepatitis C drugs.
• Comparative Analysis: Compares drugs approved before 2011 with those approved after 2013 to identify significant statistical differences in adverse event rates.
• Consistency Evaluation: Assesses concordance of results between FAERS and EHR data sources to evaluate data-source consistency.
• Demographic Adjustment: Adjusts analyses for age and gender to account for demographic variation among drug users.
• Regulatory Support: Provides a standardized pipeline for comparing and visualizing drug safety data to inform regulatory assessment of hepatitis C therapies.

Scientific Applications:

• Post-market surveillance: Systematic analysis of adverse events across hepatitis C treatments using FAERS and Cerner EHR datasets.
• Regulatory assessment: Quantitative evidence generation to support regulatory decision-making and policy evaluation for hepatitis C drugs.
• Comparative safety research: Identification and quantification of differences in adverse event rates between pre-2011 and post-2013 FDA-approved hepatitis C therapies.

Methodology:

Extracts relevant AE reports from FDA's FAERS (2004-2015) and Cerner health facts (1999-2015), then applies descriptive comparison, testing for differences among groups, and quantification of association to identify significant differences in AE rates between drug cohorts.