Real-world evidence in diabetes: relevance to clinical practice.

Real-world studies may be distinguished from traditional randomized controlled trials (RCTs) based on the study population and the setting in which the research is conducted. While RCTs are the gold standard for evaluating the efficacy and safety of new therapeutic interventions, they are typically conducted in specialized environments that may lack the everyday reality of clinical, home, and community settings. There is often a gap between efficacy shown in RCTs and the effectiveness observed in real-world settings. Real-world studies and resultant real-world data can be used to develop real-world evidence (RWE). RWE adds to the evidence from RCTs by providing additional results obtained from a broader patient population outside the constraints of RCTs to evaluate what is happening in usual clinical practice. Thus, RWE is useful in determining the effectiveness and safety of an intervention in clinical practice, and it can also provide information on health care resource utilization and costs, which are not typically evaluated in RCTs.