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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...
Autores principales: | , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2020
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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. |
format | Online Article Text |
id | pubmed-7156507 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
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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