Real-World Data Or Studies Of Competitor Drugs Can Serve As Confirmatory Evidence For US FDA

Draft guidance describes seven types of confirmatory evidence that can be used with one adequate and well-controlled clinical study to demonstrate substantial evidence of effectiveness, including evidence from expanded access, real-world data, and studies of other drugs in the same class.

Clinical trial puzzle — FDA draft guidance specifies what confirmatory evidence can support a single clinical trial • Source: Shutterstock

The US Food and Drug Administration has clarified what evidence sponsors can submit to support approval of a drug that has been studied in a single clinical trial.

The agency's draft guidance, “Demonstrating Substantial Evidence of Effectiveness Based On One Adequate And Well-Controlled Clinical Investigation and Confirmatory...