Real-world evidence for regulatory decision-making, in the era of COVID-19

How RWE can help fill evidence gaps in the current global environment to ensure patients receive safe and effective treatments with minimal delay.

Which data sources, methods, and processes support the generation of regulatory-grade RWE.

How external control arms derived from RWD can be used in regulatory approvals where RCTs are not ethical or feasible, e.g., in oncology and rare diseases.

Considerations for using RWD sources to address questions about COVID-19 treatment approaches.