How prospective real-world evidence complements passive spontaneous reporting systems to detect delayed or chronic adverse drug effects.
Passive reporting systems suffer from notorious under-reporting: less than 10% of adverse drug reactions are ever reported to regulatory authorities, skewing epidemiological calculations of drug incidence.
By querying anonymized longitudinal EHR databases (such as the FDA Sentinel System), PharmacoPlatform analyzes millions of patient charts, tracking lab biomarker changes following drug initiation to identify chronic organ toxicities in real-world populations.
Aggregating real-world evidence and spontaneous reports into standardized Periodic Benefit-Risk Evaluation Reports (PBRER) drastically reduces the human effort required for annual regulatory filings.