Real-World Data for the Drug Development in the Digital Era

Randomized clinical trials (RCTs) have long been recognized the gold standard for regulatory approval in the drug development. However, RCTs may not be feasible in some diseases and/or under certain situations and findings from RCTs may not be generalized to real-world patients in the routine clinical practice. Real-world evidence (RWE) generated from various real-world data has become more and more important for the drug development and clinical decision making in the digital era. This paper described real-world data, RWE, and RWE generation, followed by the characteristics and differences between RCTs and RWE studies. Furthermore, the challenges and limitations of real-world data and RWE studies were discussed.