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THE CLINIC

SECTION 12

ISSUE 001

PROJECTIONresearch1-3yconfidence / medium

Trial Simulators Before Patient Exposure

Projection: simulation cohorts will become the wind tunnels of clinical-AI trials, exposing brittle recruitment plans, missing-data assumptions, subgroup gaps, and workflow failures before patients are enrolled. They must never substitute for real trials. Their value is choosing safer, more informative experiments before the ethical stakes become irreversible.

Why this idea is here

What the evidence establishes.

NIH is developing multimodal AI-ready datasets; FDA guidance emphasizes study appropriateness, safety, effectiveness, and lifecycle evidence for medical software.

Source ledger

Read the sources.

  1. S01
    NIH Common Fund Bridge2AI Program Advances to Next Stage

    official program announcement / published 2026-01-30 / retrieved 2026-07-09

  2. S02
    Artificial Intelligence-Enabled Medical Devices

    official regulatory database / dated Live source · verified 2026-07-09 / retrieved 2026-07-09

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