The Digital Platform and Its Emerging Role in Decentralized Clinical Trials

Decentralized clinical trials (DCTs) are becoming increasingly popular. Digital clinical trial platforms are software environments where users complete designated clinical trial tasks, providing investigators and trial participants with efficient tools to support trial activities and streamline tria...

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Vydané v:Journal of medical Internet research Ročník 26; číslo 17; s. e47882
Hlavní autori: Copland, Rachel R, Hanke, Sten, Rogers, Amy, Mpaltadoros, Lampros, Lazarou, Ioulietta, Zeltsi, Alexandra, Nikolopoulos, Spiros, MacDonald, Thomas M, Mackenzie, Isla S
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: Canada Journal of Medical Internet Research 03.09.2024
JMIR Publications
Predmet:
Clinical trials
Clinical Trials as Topic - methods
Digital Technology
Healthcare industry software
Humans
Methods
Product development
Software
Viewpoint
United States
decentralized clinical trials
clinical trials
digitalization
digital platform
mobile phone
ISSN:1438-8871, 1439-4456, 1438-8871
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Abstract Decentralized clinical trials (DCTs) are becoming increasingly popular. Digital clinical trial platforms are software environments where users complete designated clinical trial tasks, providing investigators and trial participants with efficient tools to support trial activities and streamline trial processes. In particular, digital platforms with a modular architecture lend themselves to DCTs, where individual trial activities can correspond to specific platform modules. While design features can allow users to customize their platform experience, the real strengths of digital platforms for DCTs are enabling centralized data capture and remote monitoring of trial participants and in using digital technologies to streamline workflows and improve trial management. When selecting a platform for use in a DCT, sponsors and investigators must consider the specific trial requirements. All digital platforms are limited in their functionality and technical capabilities. Integrating additional functional modules into a central platform may solve these challenges, but few commercial platforms are open to integrating third-party components. The lack of common data standardization protocols for clinical trials will likely limit the development of one-size-fits-all digital platforms for DCTs. This viewpoint summarizes the current role of digital platforms in supporting decentralized trial activities, including a discussion of the potential benefits and challenges of digital platforms for investigators and participants. We will highlight the role of the digital platform in the development of DCTs and emphasize where existing technology is functionally limiting. Finally, we will discuss the concept of the ideal fully integrated and unified DCT and the obstacles developers must address before it can be realized.
AbstractList Decentralized clinical trials (DCTs) are becoming increasingly popular. Digital clinical trial platforms are software environments where users complete designated clinical trial tasks, providing investigators and trial participants with efficient tools to support trial activities and streamline trial processes. In particular, digital platforms with a modular architecture lend themselves to DCTs, where individual trial activities can correspond to specific platform modules. While design features can allow users to customize their platform experience, the real strengths of digital platforms for DCTs are enabling centralized data capture and remote monitoring of trial participants and in using digital technologies to streamline workflows and improve trial management. When selecting a platform for use in a DCT, sponsors and investigators must consider the specific trial requirements. All digital platforms are limited in their functionality and technical capabilities. Integrating additional functional modules into a central platform may solve these challenges, but few commercial platforms are open to integrating third-party components. The lack of common data standardization protocols for clinical trials will likely limit the development of one-size-fits-all digital platforms for DCTs. This viewpoint summarizes the current role of digital platforms in supporting decentralized trial activities, including a discussion of the potential benefits and challenges of digital platforms for investigators and participants. We will highlight the role of the digital platform in the development of DCTs and emphasize where existing technology is functionally limiting. Finally, we will discuss the concept of the ideal fully integrated and unified DCT and the obstacles developers must address before it can be realized.Decentralized clinical trials (DCTs) are becoming increasingly popular. Digital clinical trial platforms are software environments where users complete designated clinical trial tasks, providing investigators and trial participants with efficient tools to support trial activities and streamline trial processes. In particular, digital platforms with a modular architecture lend themselves to DCTs, where individual trial activities can correspond to specific platform modules. While design features can allow users to customize their platform experience, the real strengths of digital platforms for DCTs are enabling centralized data capture and remote monitoring of trial participants and in using digital technologies to streamline workflows and improve trial management. When selecting a platform for use in a DCT, sponsors and investigators must consider the specific trial requirements. All digital platforms are limited in their functionality and technical capabilities. Integrating additional functional modules into a central platform may solve these challenges, but few commercial platforms are open to integrating third-party components. The lack of common data standardization protocols for clinical trials will likely limit the development of one-size-fits-all digital platforms for DCTs. This viewpoint summarizes the current role of digital platforms in supporting decentralized trial activities, including a discussion of the potential benefits and challenges of digital platforms for investigators and participants. We will highlight the role of the digital platform in the development of DCTs and emphasize where existing technology is functionally limiting. Finally, we will discuss the concept of the ideal fully integrated and unified DCT and the obstacles developers must address before it can be realized.
Decentralized clinical trials (DCTs) are becoming increasingly popular. Digital clinical trial platforms are software environments where users complete designated clinical trial tasks, providing investigators and trial participants with efficient tools to support trial activities and streamline trial processes. In particular, digital platforms with a modular architecture lend themselves to DCTs, where individual trial activities can correspond to specific platform modules. While design features can allow users to customize their platform experience, the real strengths of digital platforms for DCTs are enabling centralized data capture and remote monitoring of trial participants and in using digital technologies to streamline workflows and improve trial management. When selecting a platform for use in a DCT, sponsors and investigators must consider the specific trial requirements. All digital platforms are limited in their functionality and technical capabilities. Integrating additional functional modules into a central platform may solve these challenges, but few commercial platforms are open to integrating third-party components. The lack of common data standardization protocols for clinical trials will likely limit the development of one-size-fits-all digital platforms for DCTs. This viewpoint summarizes the current role of digital platforms in supporting decentralized trial activities, including a discussion of the potential benefits and challenges of digital platforms for investigators and participants. We will highlight the role of the digital platform in the development of DCTs and emphasize where existing technology is functionally limiting. Finally, we will discuss the concept of the ideal fully integrated and unified DCT and the obstacles developers must address before it can be realized.
Audience Academic
Author Zeltsi, Alexandra
Mackenzie, Isla S
Copland, Rachel R
MacDonald, Thomas M
Rogers, Amy
Nikolopoulos, Spiros
Mpaltadoros, Lampros
Hanke, Sten
Lazarou, Ioulietta
AuthorAffiliation 1 MEMO Research School of Medicine University of Dundee Dundee United Kingdom
2 eHealth FH Joanneum Graz Austria
3 Information Technologies Institute Centre for Research & Technology Hellas Thessaloniki Greece
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Copyright Rachel R Copland, Sten Hanke, Amy Rogers, Lampros Mpaltadoros, Ioulietta Lazarou, Alexandra Zeltsi, Spiros Nikolopoulos, Thomas M MacDonald, Isla S Mackenzie. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 03.09.2024.
COPYRIGHT 2024 Journal of Medical Internet Research
Rachel R Copland, Sten Hanke, Amy Rogers, Lampros Mpaltadoros, Ioulietta Lazarou, Alexandra Zeltsi, Spiros Nikolopoulos, Thomas M MacDonald, Isla S Mackenzie. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 03.09.2024. 2024
Copyright_xml – notice: Rachel R Copland, Sten Hanke, Amy Rogers, Lampros Mpaltadoros, Ioulietta Lazarou, Alexandra Zeltsi, Spiros Nikolopoulos, Thomas M MacDonald, Isla S Mackenzie. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 03.09.2024.
– notice: COPYRIGHT 2024 Journal of Medical Internet Research
– notice: Rachel R Copland, Sten Hanke, Amy Rogers, Lampros Mpaltadoros, Ioulietta Lazarou, Alexandra Zeltsi, Spiros Nikolopoulos, Thomas M MacDonald, Isla S Mackenzie. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 03.09.2024. 2024
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Issue 17
Keywords decentralized clinical trials
clinical trials
digitalization
digital platform
mobile phone
Language English
License Rachel R Copland, Sten Hanke, Amy Rogers, Lampros Mpaltadoros, Ioulietta Lazarou, Alexandra Zeltsi, Spiros Nikolopoulos, Thomas M MacDonald, Isla S Mackenzie. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 03.09.2024.
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Snippet Decentralized clinical trials (DCTs) are becoming increasingly popular. Digital clinical trial platforms are software environments where users complete...
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SubjectTerms Clinical trials
Clinical Trials as Topic - methods
Digital Technology
Healthcare industry software
Humans
Methods
Product development
Software
Viewpoint
Title The Digital Platform and Its Emerging Role in Decentralized Clinical Trials
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