The Missing Reality of Real Life in Real‐World Evidence

Reality is defined as a real event, a real thing, or state of affairs. Reality exists in the places where we live our daily lives, in the relationships we have with others, and in our experiences, circumstances, and situations that occur across the lifespan. As the everydayness of our lives becomes increasingly digitized, data generated from the reality that exists outside of our healthcare encounters holds much promise to fill recognized gaps in real‐world evidence (RWE). In the past decade, many factors have converged to uniquely position person‐generated data for use in health care delivery, payment reform, product development, and regulatory decision making. Yet, real‐world data will fall short of its promise to fill gaps in RWE if what we learn does not reflect the real lives of real people from across the spectrum of social, economic, and cultural experiences.