Real-World Evidence: Observational Studies Deserve More Respect In US FDA Framework

30 Apr 2019

Biopharma industry urges agency to open the door wider to use of non-randomized observational studies to support efficacy claims, but insurer Kaiser Permanente calls such studies problematic.

High resolution green, fresh and natural 3d conceptual grass over a blue sky background, a opened door at horizon ideal for religion,home,recreation,faith,business,success,oportunity or future — Industry wants an open door for use of observational studies to support efficacy claims. • Source: Shutterstock

The US Food and Drug Administration should take a more welcoming view on the use of observational studies to support new efficacy claims for approved drugs, the pharmaceutical industry believes.

Concerns about bias and the lack of randomization in observational studies need not derail the use of such real-world evidence...