Medical Affairs and Scientific Communications Forum

Real-world data (RWD) and real world evidence (RWE) play an increasing role in healthcare decisions. RWD is derived from multiple sources outside typical clinical research settings, including electronic health records (EHRs), claims and billing data, product and disease registries, and data gathered through personal devices and health applications. RWE is the intersection between the structured rigor of a randomized control trial and the clinical exposure a treatment receives once it enters clinical practice as it is derived from analysis of RWD. Medical information departments vary in their understanding and approach to the 3 D’s (definition, decision makers, and dissemination) of RWE. As the US healthcare system continues to seek value for patients, it is increasingly important to have strategies for addressing RWE across the continuum of decision makers (regulators, payers, HCPs and patients).