Attempt to replicate clinical trials with real-world data generates real-world criticism, too

It’s one of the most seductive ideas in medicine: that “real-world evidence,” including data from electronic health record systems and even records of insurance payouts, could replace the far more expensive and time-consuming studies currently considered the gold standard.

The Food and Drug Administration is required, under the 21st Century Cures Act, to explore this idea. And late last month, New York private health care company Aetion published the findings of a study in which real-world evidence was used to try to replicate the results of a specific randomized, controlled clinical trial.

Did it work? It depends on who you ask.

Aetion’s co-founder, Dr. Sebastian Schneeweiss of Brigham and Women’s Hospital, argued that the study was