Digitizing clinical trials

Abstract Clinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs and medical devices and other health system interventions. The traditional clinical trials system acts as a quality funnel for the development and implementation of new drugs, devices and health sys...

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Autores principales:	O. T. Inan, P. Tenaerts, S. A. Prindiville, H. R. Reynolds, D. S. Dizon, K. Cooper-Arnold, M. Turakhia, M. J. Pletcher, K. L. Preston, H. M. Krumholz, B. M. Marlin, K. D. Mandl, P. Klasnja, B. Spring, E. Iturriaga, R. Campo, P. Desvigne-Nickens, Y. Rosenberg, S. R. Steinhubl, R. M. Califf
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2020
Materias:	Computer applications to medicine. Medical informatics R858-859.7
Acceso en línea:	https://doaj.org/article/74588ba7851c4d4086f8aa8b6b55488d
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spelling	oai:doaj.org-article:74588ba7851c4d4086f8aa8b6b55488d2021-12-02T16:31:00ZDigitizing clinical trials10.1038/s41746-020-0302-y2398-6352https://doaj.org/article/74588ba7851c4d4086f8aa8b6b55488d2020-07-01T00:00:00Zhttps://doi.org/10.1038/s41746-020-0302-yhttps://doaj.org/toc/2398-6352Abstract Clinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs and medical devices and other health system interventions. The traditional clinical trials system acts as a quality funnel for the development and implementation of new drugs, devices and health system interventions. The concept of a “digital clinical trial” involves leveraging digital technology to improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation, and has the potential to transform clinical trials and to lower their cost. In April 2019, the US National Institutes of Health (NIH) and the National Science Foundation (NSF) held a workshop bringing together experts in clinical trials, digital technology, and digital analytics to discuss strategies to implement the use of digital technologies in clinical trials while considering potential challenges. This position paper builds on this workshop to describe the current state of the art for digital clinical trials including (1) defining and outlining the composition and elements of digital trials; (2) describing recruitment and retention using digital technology; (3) outlining data collection elements including mobile health, wearable technologies, application programming interfaces (APIs), digital transmission of data, and consideration of regulatory oversight and guidance for data security, privacy, and remotely provided informed consent; (4) elucidating digital analytics and data science approaches leveraging artificial intelligence and machine learning algorithms; and (5) setting future priorities and strategies that should be addressed to successfully harness digital methods and the myriad benefits of such technologies for clinical research.O. T. InanP. TenaertsS. A. PrindivilleH. R. ReynoldsD. S. DizonK. Cooper-ArnoldM. TurakhiaM. J. PletcherK. L. PrestonH. M. KrumholzB. M. MarlinK. D. MandlP. KlasnjaB. SpringE. IturriagaR. CampoP. Desvigne-NickensY. RosenbergS. R. SteinhublR. M. CaliffNature PortfolioarticleComputer applications to medicine. Medical informaticsR858-859.7ENnpj Digital Medicine, Vol 3, Iss 1, Pp 1-7 (2020)
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 O. T. Inan P. Tenaerts S. A. Prindiville H. R. Reynolds D. S. Dizon K. Cooper-Arnold M. Turakhia M. J. Pletcher K. L. Preston H. M. Krumholz B. M. Marlin K. D. Mandl P. Klasnja B. Spring E. Iturriaga R. Campo P. Desvigne-Nickens Y. Rosenberg S. R. Steinhubl R. M. Califf Digitizing clinical trials
description	Abstract Clinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs and medical devices and other health system interventions. The traditional clinical trials system acts as a quality funnel for the development and implementation of new drugs, devices and health system interventions. The concept of a “digital clinical trial” involves leveraging digital technology to improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation, and has the potential to transform clinical trials and to lower their cost. In April 2019, the US National Institutes of Health (NIH) and the National Science Foundation (NSF) held a workshop bringing together experts in clinical trials, digital technology, and digital analytics to discuss strategies to implement the use of digital technologies in clinical trials while considering potential challenges. This position paper builds on this workshop to describe the current state of the art for digital clinical trials including (1) defining and outlining the composition and elements of digital trials; (2) describing recruitment and retention using digital technology; (3) outlining data collection elements including mobile health, wearable technologies, application programming interfaces (APIs), digital transmission of data, and consideration of regulatory oversight and guidance for data security, privacy, and remotely provided informed consent; (4) elucidating digital analytics and data science approaches leveraging artificial intelligence and machine learning algorithms; and (5) setting future priorities and strategies that should be addressed to successfully harness digital methods and the myriad benefits of such technologies for clinical research.
format	article
author	O. T. Inan P. Tenaerts S. A. Prindiville H. R. Reynolds D. S. Dizon K. Cooper-Arnold M. Turakhia M. J. Pletcher K. L. Preston H. M. Krumholz B. M. Marlin K. D. Mandl P. Klasnja B. Spring E. Iturriaga R. Campo P. Desvigne-Nickens Y. Rosenberg S. R. Steinhubl R. M. Califf
author_facet	O. T. Inan P. Tenaerts S. A. Prindiville H. R. Reynolds D. S. Dizon K. Cooper-Arnold M. Turakhia M. J. Pletcher K. L. Preston H. M. Krumholz B. M. Marlin K. D. Mandl P. Klasnja B. Spring E. Iturriaga R. Campo P. Desvigne-Nickens Y. Rosenberg S. R. Steinhubl R. M. Califf
author_sort	O. T. Inan
title	Digitizing clinical trials
title_short	Digitizing clinical trials
title_full	Digitizing clinical trials
title_fullStr	Digitizing clinical trials
title_full_unstemmed	Digitizing clinical trials
title_sort	digitizing clinical trials
publisher	Nature Portfolio
publishDate	2020
url	https://doaj.org/article/74588ba7851c4d4086f8aa8b6b55488d
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Digitizing clinical trials

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