Defining and Standardizing Vocal Biomarker Outcomes Working Group
Chairs: Alex Cohen, PhD; Jan Sedway, PhD
Upcoming Activity: Working Group Meeting, 2026 Autumn Conference, 16-17 September 2026, Philadelphia, PA
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.
Work to date:
Since June 2025, the ISCTM Vocal Biomarkers working group has met monthly, including at ISCTM Fall 2025 and Spring 2026 meetings, to develop a manuscript on speech latency in depression clinical trials. Initial manuscript submission is expected prior to the Fall 2026 ISCTM meeting in Philadelphia.
A second focus of the group has been on determining an appropriate regulatory pathway for speech latency. Plans are currently underway to request a Critical Path Innovation Meeting (CPIM) with the FDA to get input about next steps. If a meeting is granted, preparing for it will be a second major focus of the working group. Additional support may also be needed following the meeting, to work on implementing the recommended approach (i.e. Drug Development Tool Clinical Outcome Assessment (DDT COA) qualification, Biomarker qualification, Model Informed Drug Development (MIDD), etc.).
Working Group Objectives:
The working group objectives are:
- Discuss next steps for the regulatory process, what needs to be done and who can help to support these tasks
Most Recent Activity: Working Group Meeting, 22nd Annual Scientific Meeting, 18-20 February 2026, Washington DC – View slides
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