Vinay Prasad

Prasad argues that labeling AI clinical studies as 'phase 1' is nonsensical since patients already widely use AI.

But if I put on my common sense hat, I would argue that it's not a phase 1 study. Phase one studies are nonsensical in this context. Patients are already using AI to navigate their questions and understanding on medicine and every other topic under the sun.

Prasad criticizes studies where doctors grade answers from multiple AI models, noting models change before publication, making results uninformative.

Why are we asking questions to three different AI machines and then having random doctors grade the results? By the time that paper is published, the AIS are all different. What does that answer exactly?

Prasad says that if AI is claimed to improve patient outcomes, it should be tested in randomized trials comparing usual care with AI integration.

Instead, many believe that AI improves patient outcomes. In that case, you should do… spoilers to follow… drum roll please.. a randomized study. It turns out it's simple. You randomize people to doing things the way you're currently doing them, or to integrate the AI.

Prasad urges AI trials to use patient-relevant endpoints like hospital length of stay or 30-day mortality rather than surveys.

Here's the tricky part: you measure something that actually matters to patients. You measure their length of stay in the hospital, or their 30-day mortality.

Prasad warns that no randomized outcome trials of hospital AI exist yet, even as AI is being pushed into clinical workflows.

But we don't have those studies. I’ve yet to see a single one. In the meantime, AI is the cow. Someone's pushing it wherever we walk.