New Research: Real World Evidence

  • This page as PDF


New Avalere research shows market demand for real world evidence (RWE), but a lack of stakeholder consensus on how to define it.
Please note: This is an archived post. Some of the information and data discussed in this article may be out of date. It is preserved here for historical reference but should not be used as the basis for business decisions. Please see our main Insights section for more recent posts.

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.

Webinar | A Closer Look at Patient Support Avalere experts explored how potential implications of the Inflation Reduction Act (IRA)’s out-of-pocket cap, in addition to other key regulatory and policy activities shaping benefit design and patient cost-share (e.g., EHB), could impact patient commercial and foundation assistance. Learn More
Watch Now

Sign up to receive more insights about RWE and Patient-Centered Outcomes
Please enter your email address to be notified when new RWE and Patient-Centered Outcomes insights are published.

Back To Top