Vinay Prasad on Unvalidated Surrogate Endpoints: warns against

What Prasad says

Dr. Vinay Prasad warns against approving drugs on unvalidated surrogate endpoints without requiring post-marketing confirmatory studies. His meta-analyses found surrogate endpoints had only “low or moderate” correlation with overall survival; in his studies, only 5 of 36 drugs approved on surrogates later showed a survival benefit.

His stated reasoning

Prasad’s stated reasoning is that surrogates — lab values, imaging measures, biomarkers — are guesses about patient benefit, not proof of it. When approval rests on them with no follow-up requirement, he says, ineffective drugs can remain on the market for years while patients mistake proxy improvements for real health gains.

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