Observational real-world evidence-based studies have several advantages over randomized, controlled trials, including lower cost, increased speed of research, and a broader range of patients. However, concern about inherent bias in these studies has limited their use in comparing treatments. Observational studies have been primarily used when randomized, controlled trials would be impossible or unethical.
when applying modern statistical methodologies to observational studies, the results are generally not quantitatively or qualitatively different from those obtained in randomized, controlled trials.