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Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)

Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few. Although this diversity is undoubtedly valuab...

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Autores principales: Goldsack, Jennifer C., Coravos, Andrea, Bakker, Jessie P., Bent, Brinnae, Dowling, Ariel V., Fitzer-Attas, Cheryl, Godfrey, Alan, Godino, Job G., Gujar, Ninad, Izmailova, Elena, Manta, Christine, Peterson, Barry, Vandendriessche, Benjamin, Wood, William A., Wang, Ke Will, Dunn, Jessilyn
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7156507/
https://www.ncbi.nlm.nih.gov/pubmed/32337371
http://dx.doi.org/10.1038/s41746-020-0260-4
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author Goldsack, Jennifer C.
Coravos, Andrea
Bakker, Jessie P.
Bent, Brinnae
Dowling, Ariel V.
Fitzer-Attas, Cheryl
Godfrey, Alan
Godino, Job G.
Gujar, Ninad
Izmailova, Elena
Manta, Christine
Peterson, Barry
Vandendriessche, Benjamin
Wood, William A.
Wang, Ke Will
Dunn, Jessilyn
author_facet Goldsack, Jennifer C.
Coravos, Andrea
Bakker, Jessie P.
Bent, Brinnae
Dowling, Ariel V.
Fitzer-Attas, Cheryl
Godfrey, Alan
Godino, Job G.
Gujar, Ninad
Izmailova, Elena
Manta, Christine
Peterson, Barry
Vandendriessche, Benjamin
Wood, William A.
Wang, Ke Will
Dunn, Jessilyn
author_sort Goldsack, Jennifer C.
collection PubMed
description Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few. Although this diversity is undoubtedly valuable, it can lead to confusion regarding terminology and best practices. There are many instances, as we detail in this paper, where a single term is used by different groups to mean different things, as well as cases where multiple terms are used to describe essentially the same concept. Our intent is to clarify core terminology and best practices for the evaluation of Biometric Monitoring Technologies (BioMeTs), without unnecessarily introducing new terms. We focus on the evaluation of BioMeTs as fit-for-purpose for use in clinical trials. However, our intent is for this framework to be instructional to all users of digital measurement tools, regardless of setting or intended use. We propose and describe a three-component framework intended to provide a foundational evaluation framework for BioMeTs. This framework includes (1) verification, (2) analytical validation, and (3) clinical validation. We aim for this common vocabulary to enable more effective communication and collaboration, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field.
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spelling pubmed-71565072020-04-24 Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs) Goldsack, Jennifer C. Coravos, Andrea Bakker, Jessie P. Bent, Brinnae Dowling, Ariel V. Fitzer-Attas, Cheryl Godfrey, Alan Godino, Job G. Gujar, Ninad Izmailova, Elena Manta, Christine Peterson, Barry Vandendriessche, Benjamin Wood, William A. Wang, Ke Will Dunn, Jessilyn NPJ Digit Med Perspective Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few. Although this diversity is undoubtedly valuable, it can lead to confusion regarding terminology and best practices. There are many instances, as we detail in this paper, where a single term is used by different groups to mean different things, as well as cases where multiple terms are used to describe essentially the same concept. Our intent is to clarify core terminology and best practices for the evaluation of Biometric Monitoring Technologies (BioMeTs), without unnecessarily introducing new terms. We focus on the evaluation of BioMeTs as fit-for-purpose for use in clinical trials. However, our intent is for this framework to be instructional to all users of digital measurement tools, regardless of setting or intended use. We propose and describe a three-component framework intended to provide a foundational evaluation framework for BioMeTs. This framework includes (1) verification, (2) analytical validation, and (3) clinical validation. We aim for this common vocabulary to enable more effective communication and collaboration, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field. Nature Publishing Group UK 2020-04-14 /pmc/articles/PMC7156507/ /pubmed/32337371 http://dx.doi.org/10.1038/s41746-020-0260-4 Text en © The Author(s) 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Perspective
Goldsack, Jennifer C.
Coravos, Andrea
Bakker, Jessie P.
Bent, Brinnae
Dowling, Ariel V.
Fitzer-Attas, Cheryl
Godfrey, Alan
Godino, Job G.
Gujar, Ninad
Izmailova, Elena
Manta, Christine
Peterson, Barry
Vandendriessche, Benjamin
Wood, William A.
Wang, Ke Will
Dunn, Jessilyn
Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)
title Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)
title_full Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)
title_fullStr Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)
title_full_unstemmed Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)
title_short Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)
title_sort verification, analytical validation, and clinical validation (v3): the foundation of determining fit-for-purpose for biometric monitoring technologies (biomets)
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7156507/
https://www.ncbi.nlm.nih.gov/pubmed/32337371
http://dx.doi.org/10.1038/s41746-020-0260-4
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