Of 50 healthcare organizations assessed, only 38 percent have developed a definition of RWE, and only 34 percent of organizations, though they did not have a formal definition, have discussed topics related to RWE. The remaining 28 percent did not have a readily available definition or public statement on RWE.
In order for RWE to be utilized successfully, stakeholders need to engage in a dialogue to develop a common understanding of what RWE is and how it can be applied meaningfully.
In this research, Avalere proposes a conceptual framework for advancing a common understanding of RWE by defining RWE as research that is designed to answer unique questions that go unanswered by other types of evidence (e.g., evidence that is presented to FDA as part of a product's approval package). To ensure that RWE meets public health needs, evidence generators, communicators and end-users must consider three critical factors when designing RWE studies: meaningful endpoints, appropriate study design, and real-world data sources.