Thoughts on Healthcare Markets & Technology
Thoughts on Healthcare Markets & Technology Podcast
The FDA Real Time Clinical Trial Announcement Quietly Dissolves Phase Gates, Breaks Biotech Capital Markets Plumbing, and Opens a Founder Sized Hole in Trial Infrastructure, Financing, and Workflow
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The FDA Real Time Clinical Trial Announcement Quietly Dissolves Phase Gates, Breaks Biotech Capital Markets Plumbing, and Opens a Founder Sized Hole in Trial Infrastructure, Financing, and Workflow

Continuous trials across all phases are live — AstraZeneca and Amgen are already in production.

The FDA RTCT announcement did not get the attention it deserved. Real-time clinical trials — where data from one phase informs the next without stopping the trial — are now operating in two live programs: AstraZeneca's Phase 2 lymphoma trial and Amgen's Phase 1b small cell lung cancer program. Paradigm Health has been validated as an ingestion layer. Th…

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