Defining and Standardizing Vocal Biomarker Outcomes Working Group
Chairs: Alex Cohen, PhD; Jan Sedway, PhD
Inaugural Activity: Working Group Meeting, 2025 Autumn Conference includes joint day with ECNP, 9-11 October 2025, Amsterdam, The Netherlands
This working group plans to address this problem statement:
To establish vocal biomarkers as recognized endpoints by regulatory bodies, it is essential to develop consistent, accurate, and precise measurement procedures. Standardization in this field will pave the way for broader acceptance and application in clinical research.
Speech latencies are particularly promising for use in clinical trials. Speech latency involves the pause time before an individual speaks, for example, when responding to an interviewer. They are typically measured as a reaction time in milliseconds, are tied to important socio-cognitive functions that potentially matter to patients and their caregivers, and have been tied to various aspects of psychopathology through correlational and experimental methods. Speech latencies are simple and transparent to compute and interpret, and can potentially be used across diverse populations, languages and cultures. For vocal biomarkers to gain acceptance from regulatory authorities and to ensure trust from stakeholders, it is crucial to precisely define and standardize their measurement.
Working Group Objectives:
A working group will be established to address the following:
1) Discuss the various methods of collecting speech latency, analyze the evidence for each approach, come to a consensus on approach recommended for FDA COA Qualification program
2) Write a manuscript detailing the above process and decisions
3) Determine and document the additional steps needed for FDA COA Qualification for Speech Latency