Bridging the divide between clinical research and clinical care in oncology: An integrated real-world evidence generation platform

Real world data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources; real-world evidence (RWE) generated by RWD analyses can become an important component of drug development programs and, potentially, regulatory decision-...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Ariel B. Bourla, Neal J. Meropol
Formato:	article
Lenguaje:	EN
Publicado:	SAGE Publishing 2021
Materias:	Computer applications to medicine. Medical informatics R858-859.7
Acceso en línea:	https://doaj.org/article/22c76d71443141fbafa3f2bd70840458
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:22c76d71443141fbafa3f2bd70840458
record_format	dspace
spelling	oai:doaj.org-article:22c76d71443141fbafa3f2bd708404582021-12-01T00:03:54ZBridging the divide between clinical research and clinical care in oncology: An integrated real-world evidence generation platform2055-207610.1177/20552076211059975https://doaj.org/article/22c76d71443141fbafa3f2bd708404582021-11-01T00:00:00Zhttps://doi.org/10.1177/20552076211059975https://doaj.org/toc/2055-2076Real world data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources; real-world evidence (RWE) generated by RWD analyses can become an important component of drug development programs and, potentially, regulatory decision-making. As a RWD source, electronic health records (EHRs) can now provide patient-level data at unparalleled depth and granularity. We propose a RWE generation framework that could maximize the synergy between RWD and prospective clinical trials by capitalizing on an emerging data curation infrastructure that may be applied to both retrospective and prospective research. In this platform, centralized data collection and monitoring could be enabled via routine EHR use, and seamlessly integrated with select intentional data capture during prospective study periods. By bridging the divide between routine care and clinical research, this integrated platform aggregates retrospective and prospective data, collected both routinely and intentionally. This approach makes clinical trial participation more available to patients, increasing the potential depth of data, representativeness and efficiency of clinical research.Ariel B. BourlaNeal J. MeropolSAGE PublishingarticleComputer applications to medicine. Medical informaticsR858-859.7ENDigital Health, Vol 7 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Computer applications to medicine. Medical informatics R858-859.7
spellingShingle	Computer applications to medicine. Medical informatics R858-859.7 Ariel B. Bourla Neal J. Meropol Bridging the divide between clinical research and clinical care in oncology: An integrated real-world evidence generation platform
description	Real world data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources; real-world evidence (RWE) generated by RWD analyses can become an important component of drug development programs and, potentially, regulatory decision-making. As a RWD source, electronic health records (EHRs) can now provide patient-level data at unparalleled depth and granularity. We propose a RWE generation framework that could maximize the synergy between RWD and prospective clinical trials by capitalizing on an emerging data curation infrastructure that may be applied to both retrospective and prospective research. In this platform, centralized data collection and monitoring could be enabled via routine EHR use, and seamlessly integrated with select intentional data capture during prospective study periods. By bridging the divide between routine care and clinical research, this integrated platform aggregates retrospective and prospective data, collected both routinely and intentionally. This approach makes clinical trial participation more available to patients, increasing the potential depth of data, representativeness and efficiency of clinical research.
format	article
author	Ariel B. Bourla Neal J. Meropol
author_facet	Ariel B. Bourla Neal J. Meropol
author_sort	Ariel B. Bourla
title	Bridging the divide between clinical research and clinical care in oncology: An integrated real-world evidence generation platform
title_short	Bridging the divide between clinical research and clinical care in oncology: An integrated real-world evidence generation platform
title_full	Bridging the divide between clinical research and clinical care in oncology: An integrated real-world evidence generation platform
title_fullStr	Bridging the divide between clinical research and clinical care in oncology: An integrated real-world evidence generation platform
title_full_unstemmed	Bridging the divide between clinical research and clinical care in oncology: An integrated real-world evidence generation platform
title_sort	bridging the divide between clinical research and clinical care in oncology: an integrated real-world evidence generation platform
publisher	SAGE Publishing
publishDate	2021
url	https://doaj.org/article/22c76d71443141fbafa3f2bd70840458
work_keys_str_mv	AT arielbbourla bridgingthedividebetweenclinicalresearchandclinicalcareinoncologyanintegratedrealworldevidencegenerationplatform AT nealjmeropol bridgingthedividebetweenclinicalresearchandclinicalcareinoncologyanintegratedrealworldevidencegenerationplatform
_version_	1718406128442802176

Bridging the divide between clinical research and clinical care in oncology: An integrated real-world evidence generation platform

Ejemplares similares