Strategies for the Use of Real-World Data to Conduct COVID-19-Related Pharmacoepidemiology

This presentation shares experiences of the US FDA’s Sentinel System during the development and implementation of its COVID-19-related studies by covering the following topics: 1) Rationale and development of a Master Protocol to identify health plan members with COVID-19 in the US FDA Sentinel System, classify COVID-19 disease severity, and ascertain relevant data elements; 2) Methods to identify persons with COVID-19 and key data elements validly within inpatient electronic health records; 3) Challenges and solutions to examining complications of COVID-19 in claims data; and 4) Approaches to enhance collaborations with researchers, data providers, and regulatory agencies to enhance the validity and generalizability of results.

It was presented as a symposium at the 37th International Conference on Pharmacoepidemiology and Therapeutic Risk Management.