Cargando…

Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View

For almost a decade, regulators and pharmaceutical industry groups have been interested in electronic source (eSource) in clinical trials (Nordo et al. in Learn Health Syst 3:e10076, 2019). eSource may provide efficiencies and value; however, eSource adoption is fragmented and slow. Acceleration of...

Descripción completa

Detalles Bibliográficos
Autores principales: Parab, Abhijit A., Mehta, Prasann, Vattikola, Arundhati, Denney, Christine K., Cherry, Michele, Maniar, Rakesh M., Kjaer, Jesper
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458943/
https://www.ncbi.nlm.nih.gov/pubmed/32128701
http://dx.doi.org/10.1007/s43441-020-00138-y
_version_ 1783576297321005056
author Parab, Abhijit A.
Mehta, Prasann
Vattikola, Arundhati
Denney, Christine K.
Cherry, Michele
Maniar, Rakesh M.
Kjaer, Jesper
author_facet Parab, Abhijit A.
Mehta, Prasann
Vattikola, Arundhati
Denney, Christine K.
Cherry, Michele
Maniar, Rakesh M.
Kjaer, Jesper
author_sort Parab, Abhijit A.
collection PubMed
description For almost a decade, regulators and pharmaceutical industry groups have been interested in electronic source (eSource) in clinical trials (Nordo et al. in Learn Health Syst 3:e10076, 2019). eSource may provide efficiencies and value; however, eSource adoption is fragmented and slow. Acceleration of eSource adoption is a critical step in modernizing the conduct of clinical trials. The desired future state is one in which all source data, acquired through any context (e.g., healthcare delivery, chronic disease management) and actor (e.g., healthcare professional, patient, caregiver), are completely electronic, adequate in quality, and fully acceptable in clinical trial submissions by regulators worldwide. Achieving this desired future state requires transformative change management to foster adoption and minimize the burden of implementing eSource. Realizing this vision requires collaborative and dedicated efforts from multiple stakeholders, including patients, clinical trial participants, sites, technology vendors, standards organizations, regulators, payers, and sponsors. Stakeholders should align upon guidance to promote data integrity, data privacy, data security, and interoperability. The eSource revolution requires open dialogue, inclusive of shared learnings among stakeholders, to collectively and rapidly advance adoption. Adoption of eSource will optimize clinical research by enabling faster access to research data and more rapid decision-making, increasing clinical trial efficiency. Furthermore, adoption of eSource will improve data integrity by allowing direct data flow from the source to the sponsor’s system, with minimal or no human intervention. This paper provides the TransCelerate point of view (POV) and recommendations to achieve the future state vision of complete utilization of eSource data in clinical trials and builds on previous TransCelerate eSource publications.
format Online
Article
Text
id pubmed-7458943
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Springer International Publishing
record_format MEDLINE/PubMed
spelling pubmed-74589432020-09-11 Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View Parab, Abhijit A. Mehta, Prasann Vattikola, Arundhati Denney, Christine K. Cherry, Michele Maniar, Rakesh M. Kjaer, Jesper Ther Innov Regul Sci Original Research For almost a decade, regulators and pharmaceutical industry groups have been interested in electronic source (eSource) in clinical trials (Nordo et al. in Learn Health Syst 3:e10076, 2019). eSource may provide efficiencies and value; however, eSource adoption is fragmented and slow. Acceleration of eSource adoption is a critical step in modernizing the conduct of clinical trials. The desired future state is one in which all source data, acquired through any context (e.g., healthcare delivery, chronic disease management) and actor (e.g., healthcare professional, patient, caregiver), are completely electronic, adequate in quality, and fully acceptable in clinical trial submissions by regulators worldwide. Achieving this desired future state requires transformative change management to foster adoption and minimize the burden of implementing eSource. Realizing this vision requires collaborative and dedicated efforts from multiple stakeholders, including patients, clinical trial participants, sites, technology vendors, standards organizations, regulators, payers, and sponsors. Stakeholders should align upon guidance to promote data integrity, data privacy, data security, and interoperability. The eSource revolution requires open dialogue, inclusive of shared learnings among stakeholders, to collectively and rapidly advance adoption. Adoption of eSource will optimize clinical research by enabling faster access to research data and more rapid decision-making, increasing clinical trial efficiency. Furthermore, adoption of eSource will improve data integrity by allowing direct data flow from the source to the sponsor’s system, with minimal or no human intervention. This paper provides the TransCelerate point of view (POV) and recommendations to achieve the future state vision of complete utilization of eSource data in clinical trials and builds on previous TransCelerate eSource publications. Springer International Publishing 2020-03-03 2020 /pmc/articles/PMC7458943/ /pubmed/32128701 http://dx.doi.org/10.1007/s43441-020-00138-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
Parab, Abhijit A.
Mehta, Prasann
Vattikola, Arundhati
Denney, Christine K.
Cherry, Michele
Maniar, Rakesh M.
Kjaer, Jesper
Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View
title Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View
title_full Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View
title_fullStr Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View
title_full_unstemmed Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View
title_short Accelerating the Adoption of eSource in Clinical Research: A Transcelerate Point of View
title_sort accelerating the adoption of esource in clinical research: a transcelerate point of view
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458943/
https://www.ncbi.nlm.nih.gov/pubmed/32128701
http://dx.doi.org/10.1007/s43441-020-00138-y
work_keys_str_mv AT parababhijita acceleratingtheadoptionofesourceinclinicalresearchatransceleratepointofview
AT mehtaprasann acceleratingtheadoptionofesourceinclinicalresearchatransceleratepointofview
AT vattikolaarundhati acceleratingtheadoptionofesourceinclinicalresearchatransceleratepointofview
AT denneychristinek acceleratingtheadoptionofesourceinclinicalresearchatransceleratepointofview
AT cherrymichele acceleratingtheadoptionofesourceinclinicalresearchatransceleratepointofview
AT maniarrakeshm acceleratingtheadoptionofesourceinclinicalresearchatransceleratepointofview
AT kjaerjesper acceleratingtheadoptionofesourceinclinicalresearchatransceleratepointofview