Journal
MULTIPLE SCLEROSIS JOURNAL
Volume 29, Issue 3, Pages 317-325Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/13524585221100401
Keywords
Decentralised; clinical trial; randomised controlled trial; multiple sclerosis; remote; digital
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Randomised controlled trials (RCTs) play a crucial role in MS research and decentralised clinical trials (DCTs) have emerged as a new approach, utilizing digital and mobile technologies for flexible and convenient participation. However, there are still gaps in knowledge regarding the design and conduct of DCTs in MS.
Randomised controlled trials (RCTs) play an important role in multiple sclerosis (MS) research, ensuring that new interventions are safe and efficacious before their introduction into clinical practice. Trials have been evolving to improve the robustness of their designs and the efficiency of their conduct. Advances in digital and mobile technologies in recent years have facilitated this process and the first RCTs with decentralised elements became possible. Decentralised clinical trials (DCTs) are conducted remotely, enabling participation of a more heterogeneous population who can participate in research activities from different locations and at their convenience. DCTs also rely on digital and mobile technologies which allows for more flexible and frequent assessments. While hospitals quickly adapted to e-health and telehealth assessments during the COVID-19 pandemic, the conduct of conventional RCTs was profoundly disrupted. In this paper, we review the existing evidence and gaps in knowledge in the design and conduct of DCTs in MS.
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