A Review of the Importance and Relevance of Real-World Data and Real-World Evidence.

Real-world data are routinely collected data associated with patient health status or delivery of health care from sources including patient registries, electronic health records (EHRs), medical claims data, or digital health technologies. Real-world evidence is generated from specified clinical real-world data and includes evidence of the use, benefits, and risks of a medical product. Analysis of real-world data is the basis of real-world evidence to support the use and potential benefits or risks of a medical product. Also, real-world insights are generated when real-world evidence is interpreted or applied by different stakeholders in the healthcare industry to inform the planning of clinical research studies, identifying research questions, relevant patient or disease groups, disease trends over time, and evaluating the commercial viability of a study, which can improve healthcare planning and implementation. The importance of standardizing and regulating the conduct and reporting of real-world studies is highlighted by the increasing number of registered studies. This article aims to review the continued importance and relevance of real-world evidence from real-world studies and data to support and refine interpretations from controlled clinical trials.