Evidence

Why clinical conversations are valid data

Clinical conversations are not noise. Multiple peer-reviewed studies show that doctor-patient audio can be converted into accurate notes and structured elements using NLP, with datasets released in the clinical NLP community and steadily improving quality. (ACL Anthology)

Ambient documentation is now in real use. Early evaluations and trials report reduced perceived burden and acceptable safety signals for AI ambient scribes in outpatient care, with ongoing randomized work. (PubMed)

What this means for Coadia

If conversations can be reliably summarized into notes and problem lists, they can also be mapped to symptoms, adverse events, and function. That is the raw material for RWE.

Real-world evidence in psychiatry today

Psychiatry already runs on large observational datasets.

Long-acting injectable antipsychotics show reduced hospitalizations and improved adherence across claims and registry studies. (PMC)
Antidepressant effectiveness and safety have been evaluated in real-world cohorts and target-trial emulations, including older adults and mixed severe populations. Results are modest but actionable. (Psychiatry Online)
Esketamine has emerging real-world safety and effectiveness data from post-approval cohorts and observational studies, complementing trial data. (Psychiatry Online)

Bottom line

RWE already changes choices in schizophrenia and TRD. It informs adherence strategy, hospitalization risk, safety monitoring, and payer conversations. (Nature)

Where regulators are headed

The FDA's RWE program is formal and active. Final guidance explains how sponsors can use EHR and claims data to support regulatory decisions. The agency's RWE portal is current and expanding. (U.S. Food and Drug Administration)

Global alignment is advancing. ICH E6(R3) encourages appropriate use of technology and quality-by-design, which fits high-fidelity RWD capture inside care. EMA's DARWIN EU operationalizes RWE generation across Europe for lifecycle decisions. (U.S. Food and Drug Administration)

Implication

Regulators are not asking whether to use RWD. They are asking how you captured it, how you cleaned it, how you traced it, and whether it answers a decision-grade question. (U.S. Food and Drug Administration)

How Coadia meets the standard

Capture with consent inside routine visits.

Structure symptoms, adverse events, and function with full provenance back to audio and timestamps.

Deliver analysis that is traceable and audit-ready for regulatory, market access, and medical affairs use.

Align to current guidance about data selection, validation, and quality. (U.S. Food and Drug Administration)