The topic of real-world evidence (RWE) has gained considerable attention recently. As health researchers, policymakers, and regulators establish standards and structure for using real-world data (RWD) as evidence in regulatory and clinical decision making, patients must be the primary focus. Since the idea of RWD is new to many in the patient community, it is important to explore the patient community’s needs, concerns, and potential contributions and uses of RWE to ensure the patient voice is considered. On July 31, 2017, the National Health Council (NHC) brought together a multi-stakeholder roundtable, with patient advocacy organizations comprising the majority of participants. The objectives were to elicit patients’ views on RWE:

1. Definitions and uses;

2. Characteristics needed for RWE to be understood and trusted; and

3. Skillsets and tools needed by patients. The purpose of this report is to describe the Roundtable, discussions, and findings.

Read the manuscript here.