MINI REVIEW article
Front. Digit. Health
Sec. Connected Health
Volume 7 - 2025 | doi: 10.3389/fdgth.2025.1619183
This article is part of the Research TopicAdvancing Vocal Biomarkers and Voice AI in Healthcare: Multidisciplinary Focus on Responsible and Effective Development and UseView all 8 articles
Master Protocols in Vocal Biomarker Development to Reduce Variability and Advance Clinical Precision: A Narrative Review
Provisionally accepted
- 1University of South Florida, Tampa, United States
- 2Luxembourg Institute of Health, Luxembourg, Luxembourg
- 3Simon Fraser University, Burnaby, British Columbia, Canada
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Vocal biomarkers, defined as acoustic or linguistic features extracted from voice samples, are an emerging innovation in medical diagnostics. Utilizing artificial intelligence, machine learning, or traditional acoustic analysis, vocal biomarkers have shown promise in detecting and monitoring conditions such as respiratory disorders and cognitive impairments. Despite their potential, the lack of standardized protocols for data collection and analysis has limited their clinical applicability. Objectives: This review assesses the current state of research on developing a master protocol for vocal biomarkers, identifying key aspects essential for reducing variability across studies. It also explores insights from digital biomarker research to inform the creation of a standardized framework for vocal biomarker development. Methods: A narrative review was conducted by searching PubMed for literature on vocal and digital biomarker development. Articles were evaluated based on their proposed frameworks and recommendations for addressing methodological inconsistencies. Results: Twenty-one relevant articles were identified, including 12 focused on vocal biomarkers and 9 addressing broader digital biomarkers. Vocal biomarker literature emphasized the lack of existing master protocols and the need for standardization. In contrast, digital biomarker research from organizations like the Digital Medicine Society offered structured frameworks applicable to voice research. There is currently no established master protocol for vocal biomarker development. This review highlights foundational elements necessary for future standardization efforts to support the clinical integration of vocal biomarkers in healthcare.
Keywords: Voice, biomarkers, Master protocol, Vocal biomarkers, digital biomarkers, voice AI, speech biomarkers
Received: 27 Apr 2025; Accepted: 12 Jun 2025.
Copyright: © 2025 Kalia, Boyer, Fagherazzi, Bélisle-Pipon and Bensoussan. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Yael Bensoussan, University of South Florida, Tampa, United States
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