Clinical trial disclosure
Clinical trial disclosure obligations are arriving in Technology, AI and Competition through two channels at once: direct regulatory pressure from the U.S. Food and Drug Administration on AI-assisted trial design and data integrity, and competition scrutiny from the U.S. Federal Trade Commission over proprietary health datasets used to train commercial models. The European Medicines Agency has also signaled that AI-generated evidence packages submitted under its clinical data transparency framework will face heightened documentation requirements. Compliance teams are not waiting for final rules; they are auditing data-sharing agreements and model documentation practices now.
Watch
- FDA draft guidance on AI/ML-assisted clinical trial design: comment period status
- FTC enforcement pattern targeting health data acquisitions by large technology platforms
- EMA Clinical Data Publication Policy revision: scope expansion to AI-generated datasets
- ClinicalTrials.gov results disclosure deadlines for trials using algorithmic endpoints
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