Vinay Prasad on Single Pivotal Trial Standard: recommends

What Prasad says

Dr. Vinay Prasad, jointly with FDA Commissioner Marty Makary in a February 2026 New England Journal of Medicine commentary, recommends that the FDA default to one “adequate and well-controlled” pivotal study plus confirmatory evidence rather than two pivotal trials. Prasad’s stated reasoning is that the two-trial requirement is “dogma” that “no longer makes sense” given modern precision in drug discovery, and that well-designed modern studies “tell a complete biologic story.”

His stated reasoning

Prasad says confirmatory evidence can come from mechanistic data, related indications, animal models, same-class drug data, or real-world evidence. He proposes reviewers weigh credibility factors — magnitude of effect, contemporary controls, pre-specified endpoints, blinding, and missing-data handling — while retaining two trials for cases that warrant them.

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