Vinay Prasad on Surrogate Endpoints Only for Accelerated Approval: recommends

What Prasad says

Dr. Vinay Prasad recommends that surrogate endpoints be used only within accelerated approval “with a post-marketing commitment for at least one trial that measures survival and quality of life — in most cases,” while opposing their use for regular approval with no follow-up requirement. The position comes from a Cancer Letter interview (2018, republished during his FDA-era coverage).

His stated reasoning

Prasad’s stated reasoning is that surrogates can be legitimate as a bridge to faster access when sponsors commit to confirming real patient benefit afterward. Without that commitment, he says, approvals on unvalidated surrogates let ineffective drugs persist on the market indefinitely.

This page chronicles a stated position of the person above. It is not medical advice and not the site's own conclusion.