Master protocols in vocal biomarker development to reduce variability and advance clinical precision: a narrative review

IntroductionVocal 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 monito...

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Main Authors: Ayush Kalia, Micah Boyer, Guy Fagherazzi, Jean-Christophe Bélisle-Pipon, Yael Bensoussan
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-06-01
Series:Frontiers in Digital Health
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Online Access:https://www.frontiersin.org/articles/10.3389/fdgth.2025.1619183/full
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author Ayush Kalia
Micah Boyer
Guy Fagherazzi
Jean-Christophe Bélisle-Pipon
Yael Bensoussan
author_facet Ayush Kalia
Micah Boyer
Guy Fagherazzi
Jean-Christophe Bélisle-Pipon
Yael Bensoussan
author_sort Ayush Kalia
collection DOAJ
description IntroductionVocal 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.ObjectivesThis 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.MethodsA 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.ResultsTwenty-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.ConclusionThere 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.
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spelling doaj-art-7151bb82336246e8aef93f17416533c12025-08-20T03:27:44ZengFrontiers Media S.A.Frontiers in Digital Health2673-253X2025-06-01710.3389/fdgth.2025.16191831619183Master protocols in vocal biomarker development to reduce variability and advance clinical precision: a narrative reviewAyush Kalia0Micah Boyer1Guy Fagherazzi2Jean-Christophe Bélisle-Pipon3Yael Bensoussan4USF Health Voice Center, Department of Otolaryngology-Head & Neck Surgery, University of South Florida, Tampa, FL, United StatesUSF Health Voice Center, Department of Otolaryngology-Head & Neck Surgery, University of South Florida, Tampa, FL, United StatesDeep Digital Phenotyping Research Unit, Department of Precision Health, Luxembourg Institute of Health, Strassen, LuxembourgDepartment of Bio-ethics, Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, CanadaUSF Health Voice Center, Department of Otolaryngology-Head & Neck Surgery, University of South Florida, Tampa, FL, United StatesIntroductionVocal 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.ObjectivesThis 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.MethodsA 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.ResultsTwenty-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.ConclusionThere 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.https://www.frontiersin.org/articles/10.3389/fdgth.2025.1619183/fullvoicebiomarkersmaster protocolvocal biomarkersdigital biomarkersvoice AI
spellingShingle Ayush Kalia
Micah Boyer
Guy Fagherazzi
Jean-Christophe Bélisle-Pipon
Yael Bensoussan
Master protocols in vocal biomarker development to reduce variability and advance clinical precision: a narrative review
Frontiers in Digital Health
voice
biomarkers
master protocol
vocal biomarkers
digital biomarkers
voice AI
title Master protocols in vocal biomarker development to reduce variability and advance clinical precision: a narrative review
title_full Master protocols in vocal biomarker development to reduce variability and advance clinical precision: a narrative review
title_fullStr Master protocols in vocal biomarker development to reduce variability and advance clinical precision: a narrative review
title_full_unstemmed Master protocols in vocal biomarker development to reduce variability and advance clinical precision: a narrative review
title_short Master protocols in vocal biomarker development to reduce variability and advance clinical precision: a narrative review
title_sort master protocols in vocal biomarker development to reduce variability and advance clinical precision a narrative review
topic voice
biomarkers
master protocol
vocal biomarkers
digital biomarkers
voice AI
url https://www.frontiersin.org/articles/10.3389/fdgth.2025.1619183/full
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AT guyfagherazzi masterprotocolsinvocalbiomarkerdevelopmenttoreducevariabilityandadvanceclinicalprecisionanarrativereview
AT jeanchristophebelislepipon masterprotocolsinvocalbiomarkerdevelopmenttoreducevariabilityandadvanceclinicalprecisionanarrativereview
AT yaelbensoussan masterprotocolsinvocalbiomarkerdevelopmenttoreducevariabilityandadvanceclinicalprecisionanarrativereview