Skip to main content

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

Publication ,  Journal Article
Goldsack, JC; Coravos, A; Bakker, JP; Bent, B; Dowling, AV; Fitzer-Attas, C; Godfrey, A; Godino, JG; Gujar, N; Izmailova, E; Manta, C; Dunn, J ...
Published in: NPJ digital medicine
January 2020

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.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

NPJ digital medicine

DOI

EISSN

2398-6352

ISSN

2398-6352

Publication Date

January 2020

Volume

3

Start / End Page

55

Related Subject Headings

  • 4203 Health services and systems
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Goldsack, J. C., Coravos, A., Bakker, J. P., Bent, B., Dowling, A. V., Fitzer-Attas, C., … Dunn, J. (2020). Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs). NPJ Digital Medicine, 3, 55. https://doi.org/10.1038/s41746-020-0260-4
Goldsack, Jennifer C., Andrea Coravos, Jessie P. Bakker, Brinnae Bent, Ariel V. Dowling, Cheryl Fitzer-Attas, Alan Godfrey, et al. “Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs).NPJ Digital Medicine 3 (January 2020): 55. https://doi.org/10.1038/s41746-020-0260-4.
Goldsack JC, Coravos A, Bakker JP, Bent B, Dowling AV, Fitzer-Attas C, et al. Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs). NPJ digital medicine. 2020 Jan;3:55.
Goldsack, Jennifer C., et al. “Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs).NPJ Digital Medicine, vol. 3, Jan. 2020, p. 55. Epmc, doi:10.1038/s41746-020-0260-4.
Goldsack JC, Coravos A, Bakker JP, Bent B, Dowling AV, Fitzer-Attas C, Godfrey A, Godino JG, Gujar N, Izmailova E, Manta C, Peterson B, Vandendriessche B, Wood WA, Wang KW, Dunn J. Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs). NPJ digital medicine. 2020 Jan;3:55.

Published In

NPJ digital medicine

DOI

EISSN

2398-6352

ISSN

2398-6352

Publication Date

January 2020

Volume

3

Start / End Page

55

Related Subject Headings

  • 4203 Health services and systems