The FDA wants to give clinical trials a makeover.

On April 28, recently departed FDA commissioner Marty Makary announced “real-time” clinical trials that would send prespecified safety signals and clinical endpoint data to the FDA, via its cloud, as a trial is happening.

The current system has significant “dead time” between the start of Phase 1 and the final submission of an approval application to the FDA, Makary said during a press conference, adding that during that period, “there is no ongoing clinical trial. Investigators and staff are doing paperwork and other tasks, many of which are tedious.”

The agency plans to deploy AI to help identify potential signals that could lead a study to be fast tracked or scrapped, Jeremy Walsh, the FDA’s chief AI officer, said during the conference. “What we’re interested in is: Can we make a decision off of less information?” he said. 

Experts are excited but also say more is needed.—CC

Across the country, hospitals are implementing AI, whether it’s scribes to take notes or agents to take calls.

But what would it be like to build a hospital with all this technology available from the start? University of Texas at Austin (UT Austin) is trying to find out.

On April 21, UT announced a $1 billion donation to build what it’s calling an “AI-native” facility and research center. Projected to open in 2030, the UT Dell Campus for Advanced Research and the UT Dell Medical Center are being designed to keep AI and technology at the center.

“Our goal is really to shift from a system that reacts to illness to one that is continuously supporting health,” Claudia Lucchinetti, VP of medical affairs at UT Austin and dean of the university’s medical school, told us.

Is the hospital of the future…entirely AI?—CM

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Despite looming Medicaid cuts, companies like Cityblock Health still see an opportunity in serving the 1 in 5 people in the US—nearly 75 million adults and children—with the public health insurance option for people with disabilities or low income.

Launched in 2017 as a spinout from Sidewalk Labs—part of Google’s parent company, Alphabet—the value-based and tech-driven care provider partners with national and regional health plans and providers to give medical, mental, and social care to over 100,000 Medicaid and dual-eligible members across 11 states. The startup has raised over $800 million in total funding and has an annual recurring revenue of over $1 billion, Chief Health Officer Alexander Billioux told us.

Billioux came to Cityblock in March. Prior to this job, he had a five-year stint at UnitedHealthcare, where he was most recently government programs chief medical officer.

We talked to him about why he came to Cityblock and the company’s strategy for success.

See the full conversation here.—CC

As AI tools are rapidly making their way into healthcare, Adrienne Kline is
one researcher leading the way in this development. Learn how she made a
de-identification tool PixelGuard and heart diagnoser Project Corazon with
private industry research money.

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