Trial QC

Speech for trial quality

In a psychiatric or dementia trial, the primary outcome is often produced in a conversation: a rated interview, or a treatment session with a facilitator in the room. When that conversation is recorded, the recording is direct evidence of what the rating and the session were made of.

We read it in two ways. A second reading of the interview, on the participant and on the scale the study already scores. And a measured account of the session: the facilitator's speech, compared between randomised arms. The same pass also returns how the conversation was conducted, read for each interviewer against their own baseline.

What a recorded conversation can tell a sponsor

Both readings use the audio a recorded interview already produces. The scale is administered and scored exactly as before.

Reading one

A second reading of the rated interview

A consistently derived reading of the participant from the same recorded interview, reported against the endpoint. It says whether the rating moved with the material it was made from.

Reading two

A measured account of the session

Where a drug is given with psychological support, the facilitator's speech is separated from the participant's and compared between randomised arms, under a test written into the analysis plan.

Common to both

One capture chain, documented

Device, operating-system build, app and analysis version travel with every file, so a site or a handset is not mistaken for a treatment.

Three layers, one pass over the same recording

Every layer below includes the interviewer. All three come back from one pass over the same audio, in one report, per rater and per interview.

01Wording
What was asked?
Scripted or not
Open or leading
“Since we last spoke”
From a transcript
02Interaction
Who led it?
Wait time before a follow-up
Rater share of speaking time
Who named a symptom first
From timestamps
03Tone
How did it sound?
Warmth through the interview
Manner after a symptom report
Effort on a slow answer
From the audio only

Interaction: who led the conversation

Read against that rater's own interviews at the same visit and in the same arm, so the patient's stage of treatment is held constant.

This interview, against the same rater's baseline
LowerUsual rangeHigher
Wait time before a follow-upSeconds from the patient finishing to the rater speaking.
Flagged for review
Rater share of speaking timeRater talk as a proportion of the interview.
Flagged for review
Who named a symptom firstShare of items where the rater raised it before the patient did.
Not flagged
How to readUsual range for this raterOne of their other interviewsThis interview, not flaggedThis interview, flagged

Tone: how the rater came across

Each rater compared with their own other interviews.

This interview, against the same rater's baseline
LowerUsual rangeHigher
Warmth through the interviewLater turns against their own opening turns.
Flagged for review
Manner after a symptom reportThe turn after a symptom, against their other turns.
Flagged for review
Effort on a slow answerSlows to meet the patient, or holds their own pace.
Not flagged
How to readUsual range for this raterOne of their other interviewsThis interview, not flaggedThis interview, flagged

The flag rule is fixed in writing and set on held-out interviews from the same rater and visit before the read.

Did the rating move, or did the participant?

When entry threshold and endpoint sit on the same instrument, regression to the mean reads as placebo response.

Same interview, twice
Rating or participant?
If the rating moved and the recorded material did not, that points to the rating for review.
Published work
Least agreement at screening
Independent re-scoring of recorded interviews agreed least at the visit that decides enrolment.
The material
The recording itself
For patient-facing scales, the recording is what the rating was made from.

What happened in the session, measured

Blinding questionnaires record guesses. The recording holds what happened in the session.

FDA guidance on psychedelic drug trials, July 2026
A question in writing
Sponsors are asked to describe design elements that evaluate the contribution of psychotherapy to the treatment effect.
Between arms
A measured check on the blind
Facilitator behaviour compared across arms, pre-specified before unblinding.
Published work
The facilitator matters
Session language, the therapist’s included, has predicted participant response.
Voice

Prosody and voice quality

Pitch contour, energy and voice quality. A warm and a flat delivery of the same sentence produce the same transcript and different acoustics.

Timing

Latency and pauses

Response latency, pause length, overlap and back-channel, measured in seconds from the audio.

Speakers

Who is speaking

Facilitator and participant separated by voice across sites, without manual annotation, so each side of the session is read on its own.

One package, from capture to read-out

Recording a rated interview or a treatment session is common practice. We package what turns that recording into evidence: the same four parts for both readings, scoped to the protocol.

A research coordinator at her desk reviewing a laptop
Step 1

Capture specification

Recording settings, task timing and consent wording, written into the protocol, with device and app versions logged on every file.

Step 2

Speakers and quality

Interviewer, facilitator and participant separated by voice, and every recording checked for level, noise and completeness before analysis.

Step 3

Pre-specified analysis

Features and the comparison drafted for the statistical analysis plan before the data exist: against the scale for interviews, between arms for sessions.

Step 4

Read-out

Results per arm and per site, each traceable to the recordings and to the analysis version that produced them.

Before the protocol locks, or on audio you already hold

Prospective

A capture specification and a pre-specified comparison, written into a protocol still in design.

Retrospective

On recordings a completed or ongoing study already holds.

Contact

Where would a recording sit in your next protocol?

Tell us what state the recordings are in and whether the protocol is still open.

Get in touch →

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