Decentralised clinical trials in multiple sclerosis research. (March 2023)

• Record Type: Journal Article
• Authors: Garjani, Afagh; Liu, Brandon Jun-Yu; Allen, Christopher Martin; Gunzler, Douglas David; Gerry, Stephen William; Planchon, Sarah Marie; das Nair, Roshan; Chataway, Jeremy; Tallantyre, Emma C; Ontaneda, Daniel; Evangelou, Nikos
• Is Part Of: Multiple sclerosis. Volume 29:Number 3(2023)
• Page Start: 317
• Page End: 325
• Publication Date: 2023-03
• Subjects: Decentralised -- clinical trial -- randomised controlled trial -- multiple sclerosis -- remote -- digital; Central nervous system -- Diseases -- Periodicals; Myelin sheath -- Diseases -- Periodicals; Inflammation -- Periodicals; Multiple sclerosis -- Periodicals; Central Nervous System Diseases -- Periodicals; Demyelinating Diseases -- Periodicals; Inflammation -- Periodicals; Multiple Sclerosis -- Periodicals; Système nerveux central -- Maladies -- Périodiques; Gaine de myéline -- Maladies -- Périodiques; Inflammation (Pathologie) -- Périodiques; Sclérose en plaques -- Périodiques; Electronic journals; 616.834005
• DOI: 10.1177/13524585221100401
• Languages: English
• ISSNs: 1352-4585

Abstract

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.