The U.S. Food and Drug Administration (FDA) defines real-world data (RWD) as the data relating to patient health status or to the delivery of healthcare routinely collected from a variety of sources and real-world evidence as the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data.
RWD and RWE are more than just buzzwords. They’re becoming increasingly important for informing healthcare decisions across a number of settings and stakeholders. RWD and RWE are being used to monitor the safety and efficacy of therapeutic interventions, to support and guide coverage and clinical practice decisions, and to support a variety of trial designs in the development of new treatments.
Despite the introduction of the 21st Century Cures Act in 2016 that required the FDA to issue guidance related to modern trial designs and evidence development, the volume of novel, expensive and life-saving therapies continues to outstrip traditional evidence pathways to evaluate their relative value. The ongoing evolution of RWE capabilities that leverage innovative research methods, study designs, and real-world observational databases to help address questions of clinical effectiveness and therapeutic value for novel therapies relative to a constantly changing treatment landscape continues to be critical.
The health economics and outcomes research (HEOR) team at Carelon Research is an innovator and driver of RWE development using a unique blend of multidisciplinary research expertise, relationships, and access to real-world observational data. Through this combination, the HEOR team at Carelon Research is generating evidence to help articulate therapeutic value from the perspectives of payers, providers, and patients using resources that enable more rapid generation of insights, underpinned with rigorous research expertise and sophistication.