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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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          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.

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          Most cited references31

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          Heart Rate Variability : Standards of Measurement, Physiological Interpretation, and Clinical Use

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                Author and article information

                Contributors
                jessilyn.dunn@duke.edu
                Journal
                NPJ Digit Med
                NPJ Digit Med
                NPJ Digital Medicine
                Nature Publishing Group UK (London )
                2398-6352
                14 April 2020
                14 April 2020
                2020
                : 3
                : 55
                Affiliations
                [1 ]Digital Medicine Society (DiMe), Boston, MA USA
                [2 ]Elektra Labs, Boston, MA USA
                [3 ]ISNI 0000 0001 2341 2786, GRID grid.116068.8, Harvard-MIT Center for Regulatory Science, ; Boston, MA USA
                [4 ]GRID grid.417285.d, Philips, ; Monroeville, PA USA
                [5 ]ISNI 0000 0004 1936 7961, GRID grid.26009.3d, Biomedical Engineering Department, , Duke University, ; Durham, NC USA
                [6 ]Takeda Pharmaceuticals, Cambridge, MA USA
                [7 ]ClinMed LLC, Dayton, NJ USA
                [8 ]ISNI 0000000121965555, GRID grid.42629.3b, Computer and Information Sciences Department, , Northumbria University, ; Newcastle-upon-Tyne, UK
                [9 ]ISNI 0000 0001 2107 4242, GRID grid.266100.3, Center for Wireless and Population Health Systems, , University of California, ; San Diego, CA USA
                [10 ]Samsung Neurologica, Danvers, MA USA
                [11 ]Curis Advisors, Cambridge, MA USA
                [12 ]Koneksa Health, New York, USA
                [13 ]Independent Consultant, Charlotte, NC USA
                [14 ]Byteflies, Antwerp, Belgium
                [15 ]ISNI 0000 0001 2164 3847, GRID grid.67105.35, Department of Electrical, Computer and Systems Engineering, , Case Western Reserve University, ; Cleveland, OH USA
                [16 ]ISNI 0000000122483208, GRID grid.10698.36, Department of Medicine, , University of North Carolina at Chapel Hill; Lineberger Comprehensive Cancer Center, ; Chapel Hill, NC USA
                [17 ]ISNI 0000 0004 1936 7961, GRID grid.26009.3d, Department of Biostatistics & Bioinformatics, , Duke University, ; Durham, NC USA
                Author information
                http://orcid.org/0000-0001-5379-3540
                http://orcid.org/0000-0002-7889-4978
                http://orcid.org/0000-0003-4049-9291
                http://orcid.org/0000-0001-7901-308X
                http://orcid.org/0000-0003-0672-0327
                http://orcid.org/0000-0002-3241-8183
                Article
                260
                10.1038/s41746-020-0260-4
                7156507
                32337371
                1b5b03df-94bc-4d54-b023-1ab96e446e09
                © 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/.

                History
                : 22 September 2019
                : 12 March 2020
                Funding
                Funded by: Duke FORGE Fellowship
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                © The Author(s) 2020

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