Randomization versus Real-World Evidence. Reply.

To the Editor:Collins et al. (Feb. 13 issue)(1)set up a false dichotomy in presenting real-world evidence (RWE) as an "unreliable" substitute for findings from randomized, controlled trials (RCTs). While the "magic" of randomization ensures balance between groups in RCTs, it cannot ensure that outcomes are representative of a given population. In the United States, RCTs involving patients with cancer represent less than 5% of U.S. adults with cancer. Patients in RCTs are also younger, healthier, and less diverse than the other 95% of patients with cancer.(2)Because it is not always feasible to conduct an RCT, particularly among . . .