학술논문
The future of clinical trials-is it virtual?
Document Type
Academic Journal
Author
Ng CE; Durham Bowel Service, County Durham and Darlington NHS Foundation Trust, Durham, DH1 5TW, UK.; NIHR Patient Recruitment Centre, Newcastle, NE4 6BE, UK.; Bowman S; Department of Arts, Design and Social Sciences, Northumbria University, Newcastle, NE1 8ST, UK.; Ling J; Independent Researcher.; Bagshaw R; Just R Ltd, Specialists in Marketing, Brand and Communications, Carlisle, CA3 8RY, UK.; Birt A; NIHR Patient Recruitment Centre, Newcastle, NE4 6BE, UK.; Yiannakou Y; Durham Bowel Service, County Durham and Darlington NHS Foundation Trust, Durham, DH1 5TW, UK.; NIHR Patient Recruitment Centre, Newcastle, NE4 6BE, UK.
Source
Publisher: Oxford University Press Country of Publication: England NLM ID: 0376542 Publication Model: Print Cited Medium: Internet ISSN: 1471-8391 (Electronic) Linking ISSN: 00071420 NLM ISO Abbreviation: Br Med Bull Subsets: MEDLINE
Subject
Language
English
Abstract
Introduction: Participant recruitment to clinical trials is often sub-optimal. Decentralized clinical trials have the potential to address challenges in traditional site-based clinical trial recruitment.
Sources of Data: This review is based on recently published literature and the experience of running a large industry-sponsored interventional trial using both traditional and decentralized methods.
Areas of Agreement: Efficient delivery of clinical trials is essential to continue to provide therapeutic improvements in a timely and cost-efficient way. Clinical trial designs are constantly evolving to achieve effective trial delivery, manage the complexity of new therapeutic algorithms and conform to cultural developments.
Areas of Controversy: Digitally innovative decentralized clinical trials may be a solution to improve recruitment and retention. Although many trials incorporate digital innovations to reduce patient burden, decentralized clinical trials allow remote access to clinical research, potentially enhancing geographical diversity as well as reducing participant burden.
Growing Points: Areas for development currently being discussed are developing a 'recruitment platform' that exploits the reach of digital connectivity, automated identification of eligible participants from volunteers, employing technology for remote interaction and exploring the logistic process of delivering the interventions.
Areas Timely for Relevant Research: The focus of development must ensure that the overall impact will widen participation and reduce inequalities in healthcare.
(© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
Sources of Data: This review is based on recently published literature and the experience of running a large industry-sponsored interventional trial using both traditional and decentralized methods.
Areas of Agreement: Efficient delivery of clinical trials is essential to continue to provide therapeutic improvements in a timely and cost-efficient way. Clinical trial designs are constantly evolving to achieve effective trial delivery, manage the complexity of new therapeutic algorithms and conform to cultural developments.
Areas of Controversy: Digitally innovative decentralized clinical trials may be a solution to improve recruitment and retention. Although many trials incorporate digital innovations to reduce patient burden, decentralized clinical trials allow remote access to clinical research, potentially enhancing geographical diversity as well as reducing participant burden.
Growing Points: Areas for development currently being discussed are developing a 'recruitment platform' that exploits the reach of digital connectivity, automated identification of eligible participants from volunteers, employing technology for remote interaction and exploring the logistic process of delivering the interventions.
Areas Timely for Relevant Research: The focus of development must ensure that the overall impact will widen participation and reduce inequalities in healthcare.
(© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)