Real-World Evidence For Accelerated Approval: NASEM Is A Tough Crowd

13 Mar 2023

• By Michael McCaughan

Biopharma companies continue to hold out hopes that Real-World Evidence can help expand use of the US FDA accelerated approval pathway by making confirmatory studies more viable. A recent National Academies of Science, Engineering and Medicine workshop suggests there is a long way to go in building a broader consensus behind the approach.

A NASEM panelist said real world data likely would be biased if used to confirm small or moderate effects after an accelerated approval. • Source: Shutterstock

One of the key messages from a two-day National Academies of Science, Engineering and Medicine workshop on the US Food and Drug Administration’s accelerated approval pathway is the importance of assuring a credible, timely method of gathering confirmatory evidence of clinical benefit for every product.

NASEM panelists welcomed the new authorities granted to the FDA in December 2022 legislation as a step in the right...