{
  "signal_id": "SIG-2026-016",
  "observed_date": "2026-04-28",
  "category": "Clinical Trials + AI",
  "title": "FDA launches real-time clinical-trial proofs of concept",
  "what_changed": "FDA announced steps to explore real-time clinical trials using AI and data science to increase the speed of data flow, safety monitoring, and decision-making.",
  "why_it_matters": "Faster evidence generation could shorten the time between clinical signal, regulatory learning, and product decisions—directly aligned with P4L's innovation-to-impact focus.",
  "affected_actors": [
    "FDA",
    "sponsors",
    "trial sites",
    "data platforms",
    "AI developers",
    "patients"
  ],
  "decision_implication": "Monitor whether real-time trial methods become reusable regulatory infrastructure for digital health, therapeutics, and healthspan studies.",
  "status": "Proofs of concept",
  "evidence_class": "E5 — official FDA source",
  "impact": 5,
  "immediacy": 4,
  "relevance": 5,
  "novelty": 5,
  "adoption_leverage": 5,
  "priority_score": 96,
  "sources": [
    "https://www.fda.gov/news-events/press-announcements/fda-announces-major-steps-implement-real-time-clinical-trials"
  ],
  "public_slug": "/signal/2026-04-28-fda-real-time-trials/",
  "watch_conditions": [
    "Pilot designs",
    "safety gains",
    "sponsor participation",
    "data standards",
    "regulatory decisions."
  ],
  "last_verified": "2026-08-08",
  "version": "1.0"
}