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From biorepositories to data repositories: Open-access resources accelerate early R&D and validation of equitable diagnostic tools

Diagnostics are critical tools that guide clinical decision-making for patient care and support disease surveillance. Despite its importance, developers and manufacturers often note that access to specimen panels and essential reagents is one of the key challenges in developing quality diagnostics,...

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Autores principales: Peck, Roger, Storey, Helen L., Barney, Becky, Israeli, Shirli, Halas, Olivia, Oroszlan, Deborah, Brodsky, Shiri, Agarwal, Neha, Murphy, Eileen, Sagalovsky, Mariana, Cohen, Jessica, Trias, Elizabeth, Schutzer, Aaron, Boyle, David S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10426984/
https://www.ncbi.nlm.nih.gov/pubmed/37582061
http://dx.doi.org/10.1371/journal.pgph.0002044
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author Peck, Roger
Storey, Helen L.
Barney, Becky
Israeli, Shirli
Halas, Olivia
Oroszlan, Deborah
Brodsky, Shiri
Agarwal, Neha
Murphy, Eileen
Sagalovsky, Mariana
Cohen, Jessica
Trias, Elizabeth
Schutzer, Aaron
Boyle, David S.
author_facet Peck, Roger
Storey, Helen L.
Barney, Becky
Israeli, Shirli
Halas, Olivia
Oroszlan, Deborah
Brodsky, Shiri
Agarwal, Neha
Murphy, Eileen
Sagalovsky, Mariana
Cohen, Jessica
Trias, Elizabeth
Schutzer, Aaron
Boyle, David S.
author_sort Peck, Roger
collection PubMed
description Diagnostics are critical tools that guide clinical decision-making for patient care and support disease surveillance. Despite its importance, developers and manufacturers often note that access to specimen panels and essential reagents is one of the key challenges in developing quality diagnostics, particularly in low-resource settings. A recent example, as the COVID-19 pandemic unfolded there was a need for clinical samples across the globe to support the rapid development of diagnostics. To address these challenges and gaps, PATH, a global nonprofit, along with its partners collaborated to create a COVID-19 biorepository to improve access to biological samples. Since then, the need for data resources to advance universal rapid diagnostic test (RDT) readers and noninvasive clinical measurement tools for screening children have also been identified and initiated. From biospecimens to data files, there are more similarities than differences in creating open-access repositories. And to ensure equitable technologies are developed, diverse sample panels and datasets are critical in the development process. Here we share one experience in creating open-access repositories as a case study to describe the steps taken, the key factors required to establish a biorepository, the ethical and legal frameworks that guided the initiative and the lessons learned. As diagnostic tools are evolving, more forms of data are critical to de-risk and accelerate early research and development (R&D) for products serving low resource settings. Creating physical and virtual repositories of freely available, well characterized, and high quality clinical and electronic data resources defray development costs to improve equitable access and test affordability.
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spelling pubmed-104269842023-08-16 From biorepositories to data repositories: Open-access resources accelerate early R&D and validation of equitable diagnostic tools Peck, Roger Storey, Helen L. Barney, Becky Israeli, Shirli Halas, Olivia Oroszlan, Deborah Brodsky, Shiri Agarwal, Neha Murphy, Eileen Sagalovsky, Mariana Cohen, Jessica Trias, Elizabeth Schutzer, Aaron Boyle, David S. PLOS Glob Public Health Research Article Diagnostics are critical tools that guide clinical decision-making for patient care and support disease surveillance. Despite its importance, developers and manufacturers often note that access to specimen panels and essential reagents is one of the key challenges in developing quality diagnostics, particularly in low-resource settings. A recent example, as the COVID-19 pandemic unfolded there was a need for clinical samples across the globe to support the rapid development of diagnostics. To address these challenges and gaps, PATH, a global nonprofit, along with its partners collaborated to create a COVID-19 biorepository to improve access to biological samples. Since then, the need for data resources to advance universal rapid diagnostic test (RDT) readers and noninvasive clinical measurement tools for screening children have also been identified and initiated. From biospecimens to data files, there are more similarities than differences in creating open-access repositories. And to ensure equitable technologies are developed, diverse sample panels and datasets are critical in the development process. Here we share one experience in creating open-access repositories as a case study to describe the steps taken, the key factors required to establish a biorepository, the ethical and legal frameworks that guided the initiative and the lessons learned. As diagnostic tools are evolving, more forms of data are critical to de-risk and accelerate early research and development (R&D) for products serving low resource settings. Creating physical and virtual repositories of freely available, well characterized, and high quality clinical and electronic data resources defray development costs to improve equitable access and test affordability. Public Library of Science 2023-08-15 /pmc/articles/PMC10426984/ /pubmed/37582061 http://dx.doi.org/10.1371/journal.pgph.0002044 Text en © 2023 Peck et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Peck, Roger
Storey, Helen L.
Barney, Becky
Israeli, Shirli
Halas, Olivia
Oroszlan, Deborah
Brodsky, Shiri
Agarwal, Neha
Murphy, Eileen
Sagalovsky, Mariana
Cohen, Jessica
Trias, Elizabeth
Schutzer, Aaron
Boyle, David S.
From biorepositories to data repositories: Open-access resources accelerate early R&D and validation of equitable diagnostic tools
title From biorepositories to data repositories: Open-access resources accelerate early R&D and validation of equitable diagnostic tools
title_full From biorepositories to data repositories: Open-access resources accelerate early R&D and validation of equitable diagnostic tools
title_fullStr From biorepositories to data repositories: Open-access resources accelerate early R&D and validation of equitable diagnostic tools
title_full_unstemmed From biorepositories to data repositories: Open-access resources accelerate early R&D and validation of equitable diagnostic tools
title_short From biorepositories to data repositories: Open-access resources accelerate early R&D and validation of equitable diagnostic tools
title_sort from biorepositories to data repositories: open-access resources accelerate early r&d and validation of equitable diagnostic tools
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10426984/
https://www.ncbi.nlm.nih.gov/pubmed/37582061
http://dx.doi.org/10.1371/journal.pgph.0002044
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