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Digital Health Technology to Measure Drug Efficacy in Clinical Trials for Parkinson’s Disease: A Regulatory Perspective
Digital health technology (DHT), including wearable and environmental sensors, video cameras and other electronic tools, has provided new opportunities for the measurement of movement and functionality in Parkinson’s disease. Compared to current standards for evaluation of the disease (MDS-UPDRS), D...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
IOS Press
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8385502/ https://www.ncbi.nlm.nih.gov/pubmed/33459666 http://dx.doi.org/10.3233/JPD-202416 |
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author | Sacks, Leonard Kunkoski, Elizabeth |
author_facet | Sacks, Leonard Kunkoski, Elizabeth |
author_sort | Sacks, Leonard |
collection | PubMed |
description | Digital health technology (DHT), including wearable and environmental sensors, video cameras and other electronic tools, has provided new opportunities for the measurement of movement and functionality in Parkinson’s disease. Compared to current standards for evaluation of the disease (MDS-UPDRS), DHT may offer new possibilities for more frequent objective measurements of the duration, severity and frequency of disease manifestations over time, that may provide more information than periodic clinic visits. However, DHT measurements are only scientifically and medically useful if they are accurate, reliable and clinically meaningful. Verification and validation, also known as analytical validation and clinical validation, of DHT performance is important to ensure the accuracy and precision of measurements, and the specificity of findings. Given the wide range of clinical manifestations associated with Parkinson’s disease and the many tools and metrics to assess them, the challenge is to identify those that may represent a standard for use in clinical trials, and to confirm when digital measurements succeed or fall short of capturing meaningful benefits during drug development. |
format | Online Article Text |
id | pubmed-8385502 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | IOS Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-83855022021-09-09 Digital Health Technology to Measure Drug Efficacy in Clinical Trials for Parkinson’s Disease: A Regulatory Perspective Sacks, Leonard Kunkoski, Elizabeth J Parkinsons Dis Review Digital health technology (DHT), including wearable and environmental sensors, video cameras and other electronic tools, has provided new opportunities for the measurement of movement and functionality in Parkinson’s disease. Compared to current standards for evaluation of the disease (MDS-UPDRS), DHT may offer new possibilities for more frequent objective measurements of the duration, severity and frequency of disease manifestations over time, that may provide more information than periodic clinic visits. However, DHT measurements are only scientifically and medically useful if they are accurate, reliable and clinically meaningful. Verification and validation, also known as analytical validation and clinical validation, of DHT performance is important to ensure the accuracy and precision of measurements, and the specificity of findings. Given the wide range of clinical manifestations associated with Parkinson’s disease and the many tools and metrics to assess them, the challenge is to identify those that may represent a standard for use in clinical trials, and to confirm when digital measurements succeed or fall short of capturing meaningful benefits during drug development. IOS Press 2021-07-16 /pmc/articles/PMC8385502/ /pubmed/33459666 http://dx.doi.org/10.3233/JPD-202416 Text en © 2021 – The authors. Published by IOS Press https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial (CC BY-NC 4.0) License (https://creativecommons.org/licenses/by-nc/4.0/) , which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Review Sacks, Leonard Kunkoski, Elizabeth Digital Health Technology to Measure Drug Efficacy in Clinical Trials for Parkinson’s Disease: A Regulatory Perspective |
title | Digital Health Technology to Measure Drug Efficacy in Clinical Trials for Parkinson’s Disease: A Regulatory Perspective |
title_full | Digital Health Technology to Measure Drug Efficacy in Clinical Trials for Parkinson’s Disease: A Regulatory Perspective |
title_fullStr | Digital Health Technology to Measure Drug Efficacy in Clinical Trials for Parkinson’s Disease: A Regulatory Perspective |
title_full_unstemmed | Digital Health Technology to Measure Drug Efficacy in Clinical Trials for Parkinson’s Disease: A Regulatory Perspective |
title_short | Digital Health Technology to Measure Drug Efficacy in Clinical Trials for Parkinson’s Disease: A Regulatory Perspective |
title_sort | digital health technology to measure drug efficacy in clinical trials for parkinson’s disease: a regulatory perspective |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8385502/ https://www.ncbi.nlm.nih.gov/pubmed/33459666 http://dx.doi.org/10.3233/JPD-202416 |
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