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. Demonstration projects bridge the gap between theory and application by evaluating untested uncertainties in the current RWE ecosystem and informing authoritative guidance recommendations [1]. Several demonstration projects have been initiated over the past few years to build credibility in RWE. Below, we summarize 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. We also suggest next generation demonstration projects and actions to advance RWE adoption among decision-makers.
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