The Real-World Data Dilemma — Part 2: Medicine’s new black box

Medical decisions are increasingly shaped by massive datasets extracted from patient records. But who verifies how those data are processed before researchers ever see them?

Massive datasets containing the health records of millions of patients now underpin thousands of studies on drug safety, vaccines and treatment effectiveness.

Regulators are increasingly relying on them too.

Last December, then-FDA Commissioner Marty Makary announced plans to expand the agency’s use of “real-world evidence” in regulatory decisions.

“We’re …