Learning from the past to advance tomorrow’s real-world evidence: what demonstration projects have to teach us

Summary

Regulators, health technology assessment (HTA) agencies, and payers are actively exploring when, where, and how real-world evidence (RWE) can complement evidence generated from clinical trials and contribute to their decision-making. Several demonstration projects have been initiated over the past few years to build credibility in RWE. This commentary summarizes salient learnings from key demonstration projects where topics include understanding the underlying quality and reliability of real-world data (RWD), the role of study designs to estimate valid causal inferences and how to incorporate RWE into healthcare decision-making. Next generation demonstration projects and actions to advance RWE adoption among decision-makers are also suggested.