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Empowering drug development: Leveraging insights from imaging technologies to enable the advancement of digital health technologies
The US Food and Drug Administration (FDA) has publicly recognized the importance of improving drug development efficiency, deeming translational biomarkers a top priority. The use of imaging biomarkers has been associated with increased rates of drug approvals. An appropriate level of validation pro...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10014695/ https://www.ncbi.nlm.nih.gov/pubmed/36382716 http://dx.doi.org/10.1111/cts.13461 |
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author | Izmailova, Elena S. Maguire, R. Paul McCarthy, Timothy J. Müller, Martijn L. T. M. Murphy, Philip Stephenson, Diane |
author_facet | Izmailova, Elena S. Maguire, R. Paul McCarthy, Timothy J. Müller, Martijn L. T. M. Murphy, Philip Stephenson, Diane |
author_sort | Izmailova, Elena S. |
collection | PubMed |
description | The US Food and Drug Administration (FDA) has publicly recognized the importance of improving drug development efficiency, deeming translational biomarkers a top priority. The use of imaging biomarkers has been associated with increased rates of drug approvals. An appropriate level of validation provides a pragmatic way to choose and implement these biomarkers. Standardizing imaging modality selection, data acquisition protocols, and image analysis (in ways that are agnostic to equipment and algorithms) have been key to imaging biomarker deployment. The best known examples come from studies done via precompetitive collaboration efforts, which enable input from multiple stakeholders and data sharing. Digital health technologies (DHTs) provide an opportunity to measure meaningful aspects of patient health, including patient function, for extended periods of time outside of the hospital walls, with objective, sensor‐based measures. We identified the areas where learnings from the imaging biomarker field can accelerate the adoption and widespread use of DHTs to develop novel treatments. As with imaging, technical validation parameters and performance acceptance thresholds need to be established. Approaches amenable to multiple hardware options and data processing algorithms can be enabled by sharing DHT data and by cross‐validating algorithms. Data standardization and creation of shared databases will be vital. Pre‐competitive consortia (public‐private partnerships and professional societies that bring together all stakeholders, including patient organizations, industry, academic experts, and regulators) will advance the regulatory maturity of DHTs in clinical trials. |
format | Online Article Text |
id | pubmed-10014695 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-100146952023-03-16 Empowering drug development: Leveraging insights from imaging technologies to enable the advancement of digital health technologies Izmailova, Elena S. Maguire, R. Paul McCarthy, Timothy J. Müller, Martijn L. T. M. Murphy, Philip Stephenson, Diane Clin Transl Sci Reviews The US Food and Drug Administration (FDA) has publicly recognized the importance of improving drug development efficiency, deeming translational biomarkers a top priority. The use of imaging biomarkers has been associated with increased rates of drug approvals. An appropriate level of validation provides a pragmatic way to choose and implement these biomarkers. Standardizing imaging modality selection, data acquisition protocols, and image analysis (in ways that are agnostic to equipment and algorithms) have been key to imaging biomarker deployment. The best known examples come from studies done via precompetitive collaboration efforts, which enable input from multiple stakeholders and data sharing. Digital health technologies (DHTs) provide an opportunity to measure meaningful aspects of patient health, including patient function, for extended periods of time outside of the hospital walls, with objective, sensor‐based measures. We identified the areas where learnings from the imaging biomarker field can accelerate the adoption and widespread use of DHTs to develop novel treatments. As with imaging, technical validation parameters and performance acceptance thresholds need to be established. Approaches amenable to multiple hardware options and data processing algorithms can be enabled by sharing DHT data and by cross‐validating algorithms. Data standardization and creation of shared databases will be vital. Pre‐competitive consortia (public‐private partnerships and professional societies that bring together all stakeholders, including patient organizations, industry, academic experts, and regulators) will advance the regulatory maturity of DHTs in clinical trials. John Wiley and Sons Inc. 2022-12-02 /pmc/articles/PMC10014695/ /pubmed/36382716 http://dx.doi.org/10.1111/cts.13461 Text en © 2022 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Reviews Izmailova, Elena S. Maguire, R. Paul McCarthy, Timothy J. Müller, Martijn L. T. M. Murphy, Philip Stephenson, Diane Empowering drug development: Leveraging insights from imaging technologies to enable the advancement of digital health technologies |
title | Empowering drug development: Leveraging insights from imaging technologies to enable the advancement of digital health technologies |
title_full | Empowering drug development: Leveraging insights from imaging technologies to enable the advancement of digital health technologies |
title_fullStr | Empowering drug development: Leveraging insights from imaging technologies to enable the advancement of digital health technologies |
title_full_unstemmed | Empowering drug development: Leveraging insights from imaging technologies to enable the advancement of digital health technologies |
title_short | Empowering drug development: Leveraging insights from imaging technologies to enable the advancement of digital health technologies |
title_sort | empowering drug development: leveraging insights from imaging technologies to enable the advancement of digital health technologies |
topic | Reviews |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10014695/ https://www.ncbi.nlm.nih.gov/pubmed/36382716 http://dx.doi.org/10.1111/cts.13461 |
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