RWD (real-world data) is data about patient health and healthcare delivery collected from various sources, such as electronic health records, medical claims, product or disease registries, and data from mobile devices[1][6][5]. RWE (real-world evidence) is clinical evidence about the use, potential benefits, or risks of health products obtained through RWD analysis that serves to inform regulatory decisions[1][2][6]. RWD and RWE are changing the design and execution of clinical trials by making them smarter, faster and more efficient[3]. They are used to generate hypotheses, create performance goals for Bayesian analysis, create control groups from registries or electronic records, and support marketing requests[1]. The FDA defines RWE as a subset of RWD suitable for regulatory purposes if the data are relevant and reliable[1][6]. In 2019, more than half of FDA submissions for new drugs contained RWE studies, in 2020 it was 78%[7]. RWE complements randomized clinical trials by capturing broader patient populations, including those with comorbidities and long-term drug effects[2][4]. RWD sources also include patient data, surveys, and post-marketing observations[4][5].