Last week the Food and Drug Administration announced the start of two real-time clinical trials.
The proof of concept trials are a prelude to a pilot program.
To unpack the importance, or lack thereof, of this latest declaration, I talked to Amy Abernethy, former Principal Deputy Commissioner and Acting Chief Information Officer for the FDA, who has pushed for both real-time data in clinical trials and real world evidence. She currently runs Highlander Health, a research and investment platform that is funding innovation in healthcare.
She said there’s reason to be excited about the news, even if it may seem only incremental.
The news: The FDA is partnering with VC-backed Paradigm Health, a clinical trial platform, to deliver real-time signals during two separate cancer drug trials. Through this partnership, the FDA believes it will be able to see whether drugs are working, or causing harm, earlier.
The two drug sponsors are Astrazeneca and Amgen. Paradigm is already delivering real-time data about participants in Astrazeneca’s Phase 2 trial of a medication combination for a rare form of blood cancer. Participants are located at two health systems, Texas-based MD Anderson Cancer Center and the University of Pennsylvania Health System. Amgen is conducting a Phase 1b trial of a treatment for limited-stage small cell lung cancer.
What’s not new: The FDA has been working on speedier clinical trials for some time and has several programs: Real-time Oncology Review, Breakthrough Designation, Accelerated approval, Fast Track, and Priority Review. Last year, the FDA Commissioner also introduced The National Priority Review Voucher pilot.
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Abernethy tells Second Opinion that she’s optimistic about the FDA’s direction. She says there are technical hurdles the agency needs to overcome to be able to regulate drugs and devices in the future. One of the biggest problems with clinical trials historically is that the core processes remain highly manual, despite all the VC money that has flowed into improving automation.
The conversation below has been edited for clarity. We highlighted in bold the parts that we felt were most crucial from the discussion.