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Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study
BACKGROUND: Data sharing among stakeholders in the development, access, and use of drug therapies is critical but the current system and process are inefficient. METHODS: We take a Systems Engineering approach with a realistic use case to propose a scalable design for multi-stakeholder data sharing....
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7864828/ https://www.ncbi.nlm.nih.gov/pubmed/33118143 http://dx.doi.org/10.1007/s43441-020-00227-y |
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author | Nam, Kevin Larholt, Kay Hirsch, Gigi Beninger, Paul Fritsche, David Shoda, Diane Ferguson, John Bourgeois, Florence T. Palmer, Donna Katz, Karen Courtney, Matt W. |
author_facet | Nam, Kevin Larholt, Kay Hirsch, Gigi Beninger, Paul Fritsche, David Shoda, Diane Ferguson, John Bourgeois, Florence T. Palmer, Donna Katz, Karen Courtney, Matt W. |
author_sort | Nam, Kevin |
collection | PubMed |
description | BACKGROUND: Data sharing among stakeholders in the development, access, and use of drug therapies is critical but the current system and process are inefficient. METHODS: We take a Systems Engineering approach with a realistic use case to propose a scalable design for multi-stakeholder data sharing. RESULTS: We make three major contributions to the drug development and healthcare communities: first, a methodology for developing a multi-stakeholder data sharing system, with its focus on high-level requirements that influence the design of the system architecture and technology choice; second, the development of a realistic use case for long-term patient and therapy data tracking and sharing in the use of potentially curative and durable gene and cell therapies. Further, a bridge for the ‘awareness gap’ was found between the payer (Payer is organization which takes care of financial and operational aspects (which include insurance plans, provider network) of providing health care to US citizens. Or refer to health care insurers.) and the regulator communities by illustrating the common data tracking needs, which highlights the need for coordinated data activities; and third, a proposed system architecture for scalable, multi-stakeholder data sharing. Next steps are briefly discussed. CONCLUSION: We present a system design for multiple stakeholders such as the payer, the regulator, the developer (drug manufacturer), and the healthcare provider to share data for their decision-making. The stakeholder community would benefit from collaboratively moving the system development proposal forward for efficient and cost-effective data sharing. |
format | Online Article Text |
id | pubmed-7864828 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-78648282021-02-16 Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study Nam, Kevin Larholt, Kay Hirsch, Gigi Beninger, Paul Fritsche, David Shoda, Diane Ferguson, John Bourgeois, Florence T. Palmer, Donna Katz, Karen Courtney, Matt W. Ther Innov Regul Sci Original Research BACKGROUND: Data sharing among stakeholders in the development, access, and use of drug therapies is critical but the current system and process are inefficient. METHODS: We take a Systems Engineering approach with a realistic use case to propose a scalable design for multi-stakeholder data sharing. RESULTS: We make three major contributions to the drug development and healthcare communities: first, a methodology for developing a multi-stakeholder data sharing system, with its focus on high-level requirements that influence the design of the system architecture and technology choice; second, the development of a realistic use case for long-term patient and therapy data tracking and sharing in the use of potentially curative and durable gene and cell therapies. Further, a bridge for the ‘awareness gap’ was found between the payer (Payer is organization which takes care of financial and operational aspects (which include insurance plans, provider network) of providing health care to US citizens. Or refer to health care insurers.) and the regulator communities by illustrating the common data tracking needs, which highlights the need for coordinated data activities; and third, a proposed system architecture for scalable, multi-stakeholder data sharing. Next steps are briefly discussed. CONCLUSION: We present a system design for multiple stakeholders such as the payer, the regulator, the developer (drug manufacturer), and the healthcare provider to share data for their decision-making. The stakeholder community would benefit from collaboratively moving the system development proposal forward for efficient and cost-effective data sharing. Springer International Publishing 2020-10-28 2021 /pmc/articles/PMC7864828/ /pubmed/33118143 http://dx.doi.org/10.1007/s43441-020-00227-y Text en © The Author(s) 2020 Open AccessThis 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 licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence 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 licence, visit http://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Original Research Nam, Kevin Larholt, Kay Hirsch, Gigi Beninger, Paul Fritsche, David Shoda, Diane Ferguson, John Bourgeois, Florence T. Palmer, Donna Katz, Karen Courtney, Matt W. Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study |
title | Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study |
title_full | Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study |
title_fullStr | Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study |
title_full_unstemmed | Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study |
title_short | Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study |
title_sort | dynamic dossier in the cloud: a sociotechnical architecture for a real-time and metrics-based data tracking system with gene and cell therapies as a case study |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7864828/ https://www.ncbi.nlm.nih.gov/pubmed/33118143 http://dx.doi.org/10.1007/s43441-020-00227-y |
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