FDA pilots AI for real-time clinical trial data to speed drug development
Updated
Updated · The Wall Street Journal · Apr 28
FDA pilots AI for real-time clinical trial data to speed drug development
15 articles · Updated · The Wall Street Journal · Apr 28
The FDA will launch a pilot this summer with five to nine companies, including AstraZeneca and Amgen, using AI to extract and submit trial data in real-time.
The initiative leverages large language models and startup Paradigm Health's technology, aiming to make trials more efficient and accessible beyond major academic centers.
If successful, the program could transform clinical research, help biotech startups respond faster to trial results, and improve the U.S.'s global competitiveness in biotechnology.
Can America's AI-powered drug trials help it win the high-stakes biotech race against China?
With AI speeding up clinical trials, will life-saving medicines actually become cheaper for patients?
The FDA is using AI to accelerate cures, but can it trust the AI not to 'hallucinate' data?
How will regulators prevent AI bias from excluding certain patient groups from new drug trials?
If AI automates clinical trials, what happens to the thousands of human jobs it might replace?
AI can now read patient records for drug trials. Who is liable when it makes a mistake?