Methods for using Multi-Health Plan EHR data to conduct Active Safety Surveillance Studies of New Medical Products

Music City Center 

Conducting observational postmarket medical product safety surveillance is important for detecting rare adverse events not identified pre-licensure. New systems (e.g. CDC Vaccine Safety Datalink and FDA Sentinel Initiative) have been built for the conduct of safety surveillance using electronic healthcare data (claims and electronic medical records) from multiple healthcare systems that keeps the individual patient data within the health plan and establishes a distributed data network to share deidentified or limited data to answer important safety questions about new medical products. I will present several approaches our team have developed tailored to these networks that control for confounding, appropriate for rare events, and work within a distributed data network to protect patient privacy. I will focus the presentation on acute adverse events yielding binary outcomes, but discuss extensions of this work to survival outcomes. I will show results from a simulation study and results of the application to a real vaccine safety study.

Distributed Data

Safety Surveillance