RWE Replicates Randomizes Controlled Trial Findings as FDA Leaders Discuss Decision-Making Trends

Researchers were able to utilize real world evidence (RWE) to reproduce findings from a type 2 diabetes randomized controlled trial. In a recent article, leaders at the Food and Drug Administration (FDA) discuss RWE trends and how an increasing number of applications submitted to the FDA include RWE findings. They also discuss revised methods and the overall drug development landscape.

“Last December, an independent team of researchers published results from a study with a design identical to LEADER, but used data that came not from a massive, global, years-long trial but from already existing numbers culled from three large US insurance-claim databases. The result of this emulation using real-world data was virtually identical to what the actual trial showed, replicating both the direction and statistical significance of the original finding of the randomized controlled trial (RCT).” Read more here.

(Source: Mitchel Zoler, Medscape, 5/7/21)