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

Abstract 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 undoubted...

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Autores principales:	Jennifer C. Goldsack, Andrea Coravos, Jessie P. Bakker, Brinnae Bent, Ariel V. Dowling, Cheryl Fitzer-Attas, Alan Godfrey, Job G. Godino, Ninad Gujar, Elena Izmailova, Christine Manta, Barry Peterson, Benjamin Vandendriessche, William A. Wood, Ke Will Wang, Jessilyn Dunn
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2020
Materias:	Computer applications to medicine. Medical informatics R858-859.7
Acceso en línea:	https://doaj.org/article/1b5f94c494b5431a8b26ec28113f48ab
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spelling	oai:doaj.org-article:1b5f94c494b5431a8b26ec28113f48ab2021-12-02T15:51:17ZVerification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)10.1038/s41746-020-0260-42398-6352https://doaj.org/article/1b5f94c494b5431a8b26ec28113f48ab2020-04-01T00:00:00Zhttps://doi.org/10.1038/s41746-020-0260-4https://doaj.org/toc/2398-6352Abstract 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.Jennifer C. GoldsackAndrea CoravosJessie P. BakkerBrinnae BentAriel V. DowlingCheryl Fitzer-AttasAlan GodfreyJob G. GodinoNinad GujarElena IzmailovaChristine MantaBarry PetersonBenjamin VandendriesscheWilliam A. WoodKe Will WangJessilyn DunnNature PortfolioarticleComputer applications to medicine. Medical informaticsR858-859.7ENnpj Digital Medicine, Vol 3, Iss 1, Pp 1-15 (2020)
institution	DOAJ
collection	DOAJ
language	EN
topic	Computer applications to medicine. Medical informatics R858-859.7
spellingShingle	Computer applications to medicine. Medical informatics R858-859.7 Jennifer C. Goldsack Andrea Coravos Jessie P. Bakker Brinnae Bent Ariel V. Dowling Cheryl Fitzer-Attas Alan Godfrey Job G. Godino Ninad Gujar Elena Izmailova Christine Manta Barry Peterson Benjamin Vandendriessche William A. Wood Ke Will Wang Jessilyn Dunn Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)
description	Abstract 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.
format	article
author	Jennifer C. Goldsack Andrea Coravos Jessie P. Bakker Brinnae Bent Ariel V. Dowling Cheryl Fitzer-Attas Alan Godfrey Job G. Godino Ninad Gujar Elena Izmailova Christine Manta Barry Peterson Benjamin Vandendriessche William A. Wood Ke Will Wang Jessilyn Dunn
author_facet	Jennifer C. Goldsack Andrea Coravos Jessie P. Bakker Brinnae Bent Ariel V. Dowling Cheryl Fitzer-Attas Alan Godfrey Job G. Godino Ninad Gujar Elena Izmailova Christine Manta Barry Peterson Benjamin Vandendriessche William A. Wood Ke Will Wang Jessilyn Dunn
author_sort	Jennifer C. Goldsack
title	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_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_sort	verification, analytical validation, and clinical validation (v3): the foundation of determining fit-for-purpose for biometric monitoring technologies (biomets)
publisher	Nature Portfolio
publishDate	2020
url	https://doaj.org/article/1b5f94c494b5431a8b26ec28113f48ab
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Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)

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